Global Unique Device Identification Database; Guidance for Industry and Food and Drug Administration Staff; Availability, 36530-36532 [2014-15020]

Download as PDF 36530 Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices Dated: June 23, 2014. Leslie Kux, Assistant Commissioner for Policy. I. Background [FR Doc. 2014–15034 Filed 6–26–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–1009] Draft Guidance for Industry on Use of Nanomaterials in Food for Animals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI #220) entitled ‘‘Use of Nanomaterials in Food for Animals.’’ The draft guidance describes FDA’s current thinking regarding the use of nanomaterials or the application of nanotechnology in food for animals. It is intended to assist industry and other stakeholders in identifying potential issues related to safety or regulatory status of food for animals containing nanomaterials or otherwise involving the application of nanotechnology. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 10, 2014. ADDRESSES: Submit written requests for single copies of the guidance to the Communications Staff (HFV–12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Dragan Momcilovic, Center for Veterinary Medicine (HFV–226), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–453– 6856, dragan.momcilovic@fda.hhs.gov. wreier-aviles on DSK5TPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 15:30 Jun 26, 2014 Jkt 232001 satisfies the requirements of the applicable statutes and regulations. SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a draft guidance for industry (GFI #220) entitled ‘‘Use of Nanomaterials in Food for Animals.’’ This draft guidance applies to food ingredients that are intended for use in food for animals and either: (1) Consist entirely of nanomaterials, (2) contain nanomaterials as a component, or (3) otherwise involve the application of nanotechnology. This guidance is not applicable to other products regulated by FDA, including food substances intended for use in food for humans. This guidance also does not apply to food contact substances or color additives intended for use in food for animals or food for humans. Medicated feed contains new animal drugs approved for use in or on animal food. This guidance does not apply to a nanomaterial form of a new animal drug or drug component (e.g., drug carrier) in medicated feed. However, it does apply to nanomaterial animal food ingredients in medicated feed. This guidance is not intended to bring into question the regulatory status of animal food ingredients that naturally exist in the nanoscale range or that contain incidental amounts of particles in the nanoscale range, and that have already been determined to be generally recognized as safe or approved in response to a food additive petition. A notice announcing the availability of another draft guidance (GFI #221) entitled ‘‘Recommendations for Preparation and Submission of Animal Food Additive Petitions’’ was published in the Federal Register on September 11, 2013 (78 FR 55727). GFI #221, when finalized, would provide information regarding the submission of food additive petitions (FAPs) for animal food additives. This draft guidance (GFI #220) would provide additional information that would be useful when submitting FAPs for nanomaterial animal food additives and would supplement the information provided in GFI #221. III. Paperwork Reduction Act of 1995 This draft 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 571.1 and 571.6 have been approved under OMB control number 0910–0546; the collections of information in 21 CFR 70.25, 71.1, 170.35, 171.1, 21 CFR parts 172, 173, 179, and 180, and in Form FDA 3503, have been approved under OMB control number 0910–0016. II. Significance of Guidance Global Unique Device Identification Database; Guidance for Industry and Food and Drug Administration Staff; Availability This level 1 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 Agency’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 IV. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. V. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or https://www.regulations.gov. Dated: June 23, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–15030 Filed 6–26–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–0636] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled SUMMARY: E:\FR\FM\27JNN1.SGM 27JNN1 wreier-aviles on DSK5TPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices ‘‘Global Unique Device Identification Database (GUDID): Guidance for Industry and Food and Drug Administration Staff.’’ This guidance finalizes, as a single document, all sections of, ‘‘Global Unique Device Identification (GUDID): Draft Guidance for Industry.’’ The guidance includes, with minor modifications, the previously finalized sections on how device labelers will interface with the GUDID, establish GUDID accounts and begin initial submissions. The guidance also finalizes the sections on the Device Identifier (DI) record, Health Level 7 Structured Product Labeling (HL7 SPL) submission, search/retrieval of devices information, and GUDID submissions and maintaining and submitting electronic records. The guidance also finalizes Appendix A—GUDID Package Information Examples. 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: 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 ‘‘Global Unique Device Identification Database (GUDID): Guidance for Industry and Food and Drug Administration Staff’’ 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 or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Bldg. 71, rm. 3128, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to the office from which you are ordering to assist in processing your request. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: For information concerning the guidance as it relates to devices regulated by CDRH: Indira Konduri, UDI Regulatory Policy Support, Center for Devices and Radiological Health, Food and Drug VerDate Mar<15>2010 15:30 Jun 26, 2014 Jkt 232001 Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 3303, Silver Spring, MD 20993–0002, 301–796–5995, email: udi@fda.hhs.gov. For information concerning the guidance as it relates to devices regulated by CBER: Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. 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 (UDI) system for medical devices along with implementation timeframes for certain medical devices. The UDI system final rule was published on September 24, 2013 (78 FR 58786). In developing the final rule, FDA solicited and considered input from a variety of stakeholders including manufacturers, global regulatory bodies, the clinical community, and patient advocates to ensure that as many perspectives as possible were incorporated. The GUDID is a critical component of the UDI System. The UDI assigned to each device is a globally unique, yet unintelligent code identifying the device, and is composed of the static DI portion and the dynamic production identifier. The GUDID will house the DI, along with key descriptive or ‘‘attribute’’ information about the device, which is reported and updated to the GUDID by the device labeler. Being unique for each device, the DI component of the UDI can be effectively used by stakeholders to access the GUDID attribute information for that device. On September 24, 2013 (78 FR 58545), FDA released a document titled ‘‘Global Unique Device Identification (GUDID): Draft Guidance for Industry’’ (the draft guidance). During the 60-day comment period, which ended on November 25, 2013, more than 300 comments were received from 21 entities. In order to finalize the sections with the most questions from GUDID submitters, FDA released the first part of this finalized guidance on June 11, 2014 (79 FR 33568), providing general information to labelers to enable them to obtain a GUDID account and begin initial submissions to the GUDID. PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 36531 FDA is now, in a single document, finalizing all sections of the draft guidance. The finalized guidance includes, with minor modifications, the previously released information on how device labelers will interface with the GUDID, establish GUDID accounts, and begin initial submissions. The principal modifications include reformatting changes to rearrange sections from 3.2. to 3.1 to improve the document flow, adding a paragraph in section 2 in response to an industry comment, and adding a paragraph in section 4 that had been inadvertently omitted in the document released on June 11, 2014. In addition, this guidance finalizes sections in the draft guidance on the DI record, HL7 SPL submission, search/ retrieval of devices information, and GUDID submissions and 21 CFR part 11 requirements. We also are finalizing Appendix A—GUDID Package Information Examples. This guidance supersedes the June 11, 2014, guidance entitled ‘‘Global Unique Device Identification Database (GUDID): Guidance for Industry.’’ Elsewhere, we continue to make available on the Internet at the FDA/UDI Web site (https://www.fda.gov/udi) updated versions of two appendices of the draft guidance: The section formerly identified as ‘‘Appendix B’’ which summarizes the device attribute information that will populate the GUDID, renamed as ‘‘GUDID Data Elements Reference Table’’ and the section formerly identified as ‘‘Appendix C’’ which summarizes the UDI formats accepted by the issuing Agencies that FDA has accredited to date, renamed as ‘‘UDI Formats by FDAAccredited Issuing Agency.’’ These two documents contain technical specifications and will not be published as a part of this guidance that describes the Agency’s interpretation of or policy on a regulatory issue. For those without Internet access or who otherwise would like to receive a hard copy of the currently updated version of either of these documents, formerly published as Appendix B and Appendix C of the draft guidance, should call the people listed under FOR FURTHER INFORMATION CONTACT to request the document(s). 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 Agency’s current thinking about the GUDID. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach for interfacing with the GUIDID may be used with prior FDA E:\FR\FM\27JNN1.SGM 27JNN1 36532 Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices approval if such approach satisfies the technical requirements of the GUDID and the requirements of the applicable statute and regulations. If you wish to use an alternative approach for submitting a specific required data element, you may request FDA approval by email or writing to: UDI Regulatory Policy Support, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 3303, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, email: udi@ fda.hhs.gov (Attention: UDI Regulatory Policy Support). If a labeler has a waiver from electronic submission of GUDID data under 21 CFR 830.320(c), the labeler should send a letter containing all of the information otherwise required by this guidance, as well as any permitted ancillary information that the labeler wishes to submit, within the time permitted to: UDI Regulatory Policy Support at the address indicated in the previous sentence. See 21 CFR 830.320(c)(3). wreier-aviles on DSK5TPTVN1PROD with NOTICES 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 CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.fda.gov/BiologicsBlood Vaccines/GuidanceCompliance RegulatoryInformation/default.htm, or at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Global Unique Device Identification Database (GUDID): Guidance for Industry’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1831 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This 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 collection of information in 21 CFR part 830 pertaining to GUDID labeler accounts and data submissions addressed in this guidance document have been approved under OMB control number 0910–0720. V. Comments Interested persons may submit either electronic comments regarding this VerDate Mar<15>2010 15:30 Jun 26, 2014 Jkt 232001 document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. Dated: June 23, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–15020 Filed 6–26–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0489] Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ‘‘Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.’’ The guidance represents our current thinking on the safety assessment of nanomaterials in cosmetic products. This guidance is intended to help industry identify the potential safety issues of nanomaterials in cosmetic products and develop a framework for evaluating them. DATES: Submit either electronic or written comments on FDA guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Office of Cosmetics and Colors, Center for Food Safety and Applied Nutrition (HFS–125), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, SUMMARY: PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Kapal Dewan, Center for Food Safety and Applied Nutrition (HFS–125), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–1130. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a guidance for industry entitled ‘‘Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.’’ This guidance is being issued consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents our current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. In the Federal Register of April 25, 2012 (77 FR 24722), we made available a draft guidance entitled ‘‘Guidance for Industry: Safety of Nanomaterials in Cosmetic Products’’ and gave interested parties an opportunity to submit comments by July 24, 2012, for us to consider before beginning work on the final version of the guidance. We received several comments on the draft guidance and have modified the final guidance where appropriate. Changes to the guidance include: • The addition of several references, such as references pertaining to analytical techniques for measuring physicochemical properties of nanomaterials; • Revised text concerning potential differences between nanomaterials and their larger-scale counterparts with the same chemical composition. For example, the guidance discusses how the small particle size of a nanomaterial has the potential to alter biodistribution and bioavailability; • New text concerning thorough characterization of nanomaterials; and • Revised text concerning toxicology considerations and toxicological testing. In addition, we made editorial changes to improve clarity. The guidance announced in this notice finalizes the draft guidance dated April 2012. II. Comments Interested persons may submit either electronic comments regarding the guidance to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It E:\FR\FM\27JNN1.SGM 27JNN1

Agencies

[Federal Register Volume 79, Number 124 (Friday, June 27, 2014)]
[Notices]
[Pages 36530-36532]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15020]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0636]


Global Unique Device Identification Database; Guidance for 
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled

[[Page 36531]]

``Global Unique Device Identification Database (GUDID): Guidance for 
Industry and Food and Drug Administration Staff.'' This guidance 
finalizes, as a single document, all sections of, ``Global Unique 
Device Identification (GUDID): Draft Guidance for Industry.'' The 
guidance includes, with minor modifications, the previously finalized 
sections on how device labelers will interface with the GUDID, 
establish GUDID accounts and begin initial submissions. The guidance 
also finalizes the sections on the Device Identifier (DI) record, 
Health Level 7 Structured Product Labeling (HL7 SPL) submission, 
search/retrieval of devices information, and GUDID submissions and 
maintaining and submitting electronic records. The guidance also 
finalizes Appendix A--GUDID Package Information Examples.

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: 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 
``Global Unique Device Identification Database (GUDID): Guidance for 
Industry and Food and Drug Administration Staff'' 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 or to 
the Office of Communication, Outreach and Development, Center for 
Biologics Evaluation and Research (CBER), Bldg. 71, rm. 3128, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to the office from which you are ordering to assist in 
processing your request.
    Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: For information concerning the 
guidance as it relates to devices regulated by CDRH: Indira Konduri, 
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: 
udi@fda.hhs.gov.
    For information concerning the guidance as it relates to devices 
regulated by CBER: Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

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 (UDI) system for medical devices along with 
implementation timeframes for certain medical devices. The UDI system 
final rule was published on September 24, 2013 (78 FR 58786).
    In developing the final rule, FDA solicited and considered input 
from a variety of stakeholders including manufacturers, global 
regulatory bodies, the clinical community, and patient advocates to 
ensure that as many perspectives as possible were incorporated. The 
GUDID is a critical component of the UDI System. The UDI assigned to 
each device is a globally unique, yet unintelligent code identifying 
the device, and is composed of the static DI portion and the dynamic 
production identifier. The GUDID will house the DI, along with key 
descriptive or ``attribute'' information about the device, which is 
reported and updated to the GUDID by the device labeler. Being unique 
for each device, the DI component of the UDI can be effectively used by 
stakeholders to access the GUDID attribute information for that device.
    On September 24, 2013 (78 FR 58545), FDA released a document titled 
``Global Unique Device Identification (GUDID): Draft Guidance for 
Industry'' (the draft guidance). During the 60-day comment period, 
which ended on November 25, 2013, more than 300 comments were received 
from 21 entities. In order to finalize the sections with the most 
questions from GUDID submitters, FDA released the first part of this 
finalized guidance on June 11, 2014 (79 FR 33568), providing general 
information to labelers to enable them to obtain a GUDID account and 
begin initial submissions to the GUDID.
    FDA is now, in a single document, finalizing all sections of the 
draft guidance. The finalized guidance includes, with minor 
modifications, the previously released information on how device 
labelers will interface with the GUDID, establish GUDID accounts, and 
begin initial submissions. The principal modifications include 
reformatting changes to rearrange sections from 3.2. to 3.1 to improve 
the document flow, adding a paragraph in section 2 in response to an 
industry comment, and adding a paragraph in section 4 that had been 
inadvertently omitted in the document released on June 11, 2014. In 
addition, this guidance finalizes sections in the draft guidance on the 
DI record, HL7 SPL submission, search/retrieval of devices information, 
and GUDID submissions and 21 CFR part 11 requirements. We also are 
finalizing Appendix A--GUDID Package Information Examples. This 
guidance supersedes the June 11, 2014, guidance entitled ``Global 
Unique Device Identification Database (GUDID): Guidance for Industry.''
    Elsewhere, we continue to make available on the Internet at the 
FDA/UDI Web site (https://www.fda.gov/udi) updated versions of two 
appendices of the draft guidance: The section formerly identified as 
``Appendix B'' which summarizes the device attribute information that 
will populate the GUDID, renamed as ``GUDID Data Elements Reference 
Table'' and the section formerly identified as ``Appendix C'' which 
summarizes the UDI formats accepted by the issuing Agencies that FDA 
has accredited to date, renamed as ``UDI Formats by FDA-Accredited 
Issuing Agency.'' These two documents contain technical specifications 
and will not be published as a part of this guidance that describes the 
Agency's interpretation of or policy on a regulatory issue. For those 
without Internet access or who otherwise would like to receive a hard 
copy of the currently updated version of either of these documents, 
formerly published as Appendix B and Appendix C of the draft guidance, 
should call the people listed under FOR FURTHER INFORMATION CONTACT to 
request the document(s).

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 
Agency's current thinking about the GUDID. It does not create or confer 
any rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach for interfacing with the GUIDID may be 
used with prior FDA

[[Page 36532]]

approval if such approach satisfies the technical requirements of the 
GUDID and the requirements of the applicable statute and regulations. 
If you wish to use an alternative approach for submitting a specific 
required data element, you may request FDA approval by email or writing 
to: UDI Regulatory Policy Support, Center for Devices and Radiological 
Health, Food and Drug Administration, Bldg. 66, Rm. 3303, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, email: udi@fda.hhs.gov 
(Attention: UDI Regulatory Policy Support). If a labeler has a waiver 
from electronic submission of GUDID data under 21 CFR 830.320(c), the 
labeler should send a letter containing all of the information 
otherwise required by this guidance, as well as any permitted ancillary 
information that the labeler wishes to submit, within the time 
permitted to: UDI Regulatory Policy Support at the address indicated in 
the previous sentence. See 21 CFR 830.320(c)(3).

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 CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or at https://www.regulations.gov. Persons unable to download an electronic copy of 
``Global Unique Device Identification Database (GUDID): Guidance for 
Industry'' may send an email request to CDRH-Guidance@fda.hhs.gov to 
receive an electronic copy of the document. Please use the document 
number 1831 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This 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 collection of information in 21 CFR part 830 pertaining to 
GUDID labeler accounts and data submissions addressed in this guidance 
document have been approved under OMB control number 0910-0720.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to https://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.

    Dated: June 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15020 Filed 6-26-14; 8:45 am]
BILLING CODE 4164-01-P
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