81_FR_28966 81 FR 28876 - Technical Considerations for Additive Manufactured Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

81 FR 28876 - Technical Considerations for Additive Manufactured Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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 90 (May 10, 2016)

Page Range28876-28878
FR Document2016-10924

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Technical Considerations for Additive Manufactured Devices.'' FDA has developed this draft leapfrog guidance to provide FDA's initial thoughts on technical considerations specific to devices using additive manufacturing, the broad category of manufacturing encompassing 3- dimensional (3D) printing. Specifically, this draft guidance outlines technical considerations associated with additive manufacturing processes, and testing and characterization for final finished devices fabricated using additive manufacturing. This draft guidance is not final nor is it in effect at this time.

Federal Register, Volume 81 Issue 90 (Tuesday, May 10, 2016)
[Federal Register Volume 81, Number 90 (Tuesday, May 10, 2016)]
[Notices]
[Pages 28876-28878]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-10924]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1210]


Technical Considerations for Additive Manufactured Devices; Draft 
Guidance for Industry and Food and Drug Administration Staff; 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 or Agency) is announcing 
the availability of the draft guidance entitled ``Technical 
Considerations for Additive Manufactured Devices.'' FDA has developed 
this draft leapfrog guidance to provide FDA's initial thoughts on 
technical considerations specific to devices using additive 
manufacturing, the broad category of manufacturing encompassing 3-
dimensional (3D) printing. Specifically, this draft guidance outlines 
technical considerations associated with additive manufacturing 
processes, and testing and characterization for final finished devices 
fabricated using additive manufacturing. This draft guidance is not 
final 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 comment of 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 August 8, 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

[[Page 28877]]

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-1210 for ``Technical Considerations for Additive 
Manufactured 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 draft guidance. Submit 
written requests for a single hard copy of the draft guidance document 
entitled ``Technical Considerations for Additive Manufactured 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; or the Office of Communication, 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 
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Matthew Di Prima, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 62, Rm. 2214, Silver Spring, MD 20993-0002, 301-
796-2507; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has developed this draft leapfrog guidance to provide FDA's 
initial thoughts on technical considerations specific to devices using 
additive manufacturing (AM), the broad category of manufacturing 
encompassing 3D printing. In medical device applications, AM has the 
advantage of facilitating the creation of anatomically-matched devices 
and surgical instrumentation by using a patient's own medical imaging. 
Another advantage is the ease in fabricating complex geometric 
structures, allowing the creation of engineered open lattice 
structures, tortuous internal channels, and internal support structures 
that would not be easily possible using traditional (non-additive) 
manufacturing approaches. However, the unique aspects of the AM 
process, such as the layer-wise fabrication process, and the relative 
lack of medical device history of devices manufactured using AM 
techniques, pose challenges in determining optimal characterization and 
assessment methods for the final finished device, as well as optimal 
process validation and verification methods for these devices. To 
discuss these challenges and obtain initial stakeholder input, the FDA 
held a public workshop entitled ``Additive Manufacturing of Medical 
Devices: An Interactive Discussion on the Technical Considerations of 
3D Printing,'' on October 8-9, 2014 (http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm397324.htm). When finalized, this 
draft guidance document will recommend technical aspects of an 
additively manufactured device that should be considered through the 
phases of development, production process, process validation, and 
final finished device testing.
    This draft guidance is a leapfrog guidance; leapfrog guidances are 
intended to serve as a mechanism by which the Agency can share initial 
thoughts regarding the content of premarket submissions for emerging 
technologies and new clinical applications that are likely to be of 
public health importance very early in product development. This 
leapfrog guidance represents the Agency's initial thinking, and our 
recommendations may change as more information becomes available. The 
Agency strongly encourages manufacturers to engage with CDRH and/or 
CBER through the Pre-Submission process to obtain more detailed 
feedback regarding their AM device or process. For more information on 
Pre-Submissions, please see ``Requests for Feedback on Medical Device 
Submissions: The Pre-Submission Program and Meetings with Food and Drug 
Administration Staff'' (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf).

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 technical 
considerations for additive manufactured 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 draft guidance may do 
so by downloading an electronic copy from the Internet. A search 
capability for all CDRH guidance documents is available at http://
www.fda.gov/MedicalDevices/

[[Page 28878]]

DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov. Persons unable to download 
an electronic copy of ``Technical Considerations for Additive 
Manufactured Devices'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 1400002 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    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 814, subparts B and E are approved under OMB control number 0910-
0231; the collections of information in 21 CFR part 814, subpart H are 
approved under OMB control number 0910-0332; the collections of 
information in 21 CFR part 807, subpart E are approved under OMB 
control number 0910-0120; the collections of information in 21 CFR part 
812 are approved under OMB control number 0910-0078; the collections of 
information in 21 CFR part 820 are approved under OMB control number 
0910-0073; the collections of information in 21 CFR parts 801 and 809 
are approved under OMB control number 0910-0485; and the collections of 
information in the guidance document entitled ``Requests for Feedback 
on Medical Device Submissions: The Pre-Submission Program and Meetings 
with Food and Drug Administration Staff'' are approved under OMB 
control number 0910-0756.

    Dated: May 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10924 Filed 5-9-16; 8:45 am]
BILLING CODE 4164-01-P



                                                    28876                          Federal Register / Vol. 81, No. 90 / Tuesday, May 10, 2016 / Notices

                                                    DEPARTMENT OF HEALTH AND                                can call 301–796–1300 to register.                    SUMMARY:   The Food and Drug
                                                    HUMAN SERVICES                                          Persons needing a sign language                       Administration (FDA or Agency) is
                                                                                                            interpreter or other special                          announcing the availability of the draft
                                                    Food and Drug Administration                            accommodations should notify Ms.                      guidance entitled ‘‘Technical
                                                    [Docket No. FDA–2016–N–0001]                            Jessica Barnes or Ms. Lori Benner (see                Considerations for Additive
                                                                                                            Contact Persons) at least 7 days in                   Manufactured Devices.’’ FDA has
                                                    Clinical Trial Design Considerations                    advance.                                              developed this draft leapfrog guidance
                                                    for Malaria Drug Development Media;                     SUPPLEMENTARY INFORMATION:       FDA is               to provide FDA’s initial thoughts on
                                                    Public Workshop                                         announcing a public workshop                          technical considerations specific to
                                                                                                            regarding scientific and regulatory                   devices using additive manufacturing,
                                                    AGENCY:    Food and Drug Administration,                                                                      the broad category of manufacturing
                                                    HHS.                                                    considerations in the design of clinical
                                                                                                            trials of antimalarial drugs. Discussions             encompassing 3-dimensional (3D)
                                                    ACTION:   Notice of public workshop.                                                                          printing. Specifically, this draft
                                                                                                            will focus on developing two or more
                                                                                                            drugs used in combination, human                      guidance outlines technical
                                                    SUMMARY:   The Food and Drug
                                                                                                            challenge studies, issues/challenges                  considerations associated with additive
                                                    Administration (FDA) is announcing a
                                                                                                            associated with current detection                     manufacturing processes, and testing
                                                    public workshop regarding clinical trial
                                                                                                            methods, use of polymerase chain                      and characterization for final finished
                                                    design considerations for malaria drug
                                                                                                            reaction, and other emerging rapid                    devices fabricated using additive
                                                    development. FDA is interested in
                                                                                                            diagnostic tests in clinical trials.                  manufacturing. This draft guidance is
                                                    discussing the scientific challenges
                                                                                                               The Agency encourages individuals,                 not final nor is it in effect at this time.
                                                    pertaining to malaria drug development
                                                    and malaria parasite detection methods                  industry, health care professionals,                  DATES: Although you can comment on
                                                    used as endpoints in clinical trials. This              researchers, public health organizations              any guidance at any time (see 21 CFR
                                                    public workshop is intended to provide                  and other interested persons to attend                10.115(g)(5)), to ensure that the Agency
                                                    information for and gain perspective                    this public workshop.                                 considers your comment of this draft
                                                    from health care providers, other U.S.                     Transcripts: Please be advised that as             guidance before it begins work on the
                                                    government agencies, public health                      soon as a transcript is available, it will            final version of the guidance, submit
                                                    organizations, academic experts, and                    be accessible at http://                              either electronic or written comments
                                                    industry on various aspects of the                      www.regulations.gov. It may be viewed                 on the draft guidance by August 8, 2016.
                                                    design of clinical trials evaluating new                at the Division of Dockets Management                 ADDRESSES: You may submit comments
                                                    drugs to treat malaria. The input from                  (HFA–305), Food and Drug                              as follows:
                                                    this public workshop will also help in                  Administration, 5630 Fishers Lane, Rm.
                                                                                                            1061, Rockville, MD. A transcript will                Electronic Submissions
                                                    developing topics for future discussion.
                                                       Dates and Times: The public                          also be available in either hard copy or                Submit electronic comments in the
                                                    workshop will be held on June 30, 2016,                 on CD–ROM, after submission of a                      following way:
                                                    from 8:30 a.m. to 4 p.m.                                Freedom of Information request. Written                 • Federal eRulemaking Portal: http://
                                                       Location: The public workshop will                   requests are to be sent to Division of                www.regulations.gov. Follow the
                                                    be held at FDA’s White Oak campus,                      Freedom of Information (HFI–35), Office               instructions for submitting comments.
                                                    10903 New Hampshire Ave., Bldg. 31                      of Management Programs, Food and                      Comments submitted electronically,
                                                    Great Rm., Silver Spring, MD 20993.                     Drug Administration, 5600 Fishers                     including attachments, to http://
                                                    Entrance for the public workshop                        Lane, Rm. 6–30, Rockville, MD 20857.                  www.regulations.gov will be posted to
                                                    participants (non-FDA employees) is                     Transcripts will also be available on the             the docket unchanged. Because your
                                                    through Building 1 where routine                        Internet at http://wcms.fda.gov/FDAgov/               comment will be made public, you are
                                                    security check procedures will be                       Drugs/NewsEvents/                                     solely responsible for ensuring that your
                                                    performed. For parking and security                     ucm490084.htm?SSContributor=true                      comment does not include any
                                                    information, please refer to http://                    approximately 45 days after the                       confidential information that you or a
                                                    www.fda.gov/AboutFDA/                                   workshop.                                             third party may not wish to be posted,
                                                    WorkingatFDA/BuildingsandFacilities/                      Dated: May 4, 2016.                                 such as medical information, your or
                                                    WhiteOakCampusInformation/                              Leslie Kux,
                                                                                                                                                                  anyone else’s Social Security number, or
                                                    ucm241740.htm. Seating is limited and                                                                         confidential business information, such
                                                                                                            Associate Commissioner for Policy.
                                                    available only on a first-come, first-                                                                        as a manufacturing process. Please note
                                                                                                            [FR Doc. 2016–10913 Filed 5–9–16; 8:45 am]
                                                    served basis.                                                                                                 that if you include your name, contact
                                                       Contact Persons: Ms. Lori Benner                     BILLING CODE 4164–01–P                                information, or other information that
                                                    and/or Ms. Jessica Barnes, Center for                                                                         identifies you in the body of your
                                                    Drug Evaluation and Research, Food                                                                            comments, that information will be
                                                    and Drug Administration, Bldg. 22, Rm.                  DEPARTMENT OF HEALTH AND                              posted on http://www.regulations.gov.
                                                    6221, 10903 New Hampshire Ave.,                         HUMAN SERVICES                                          • If you want to submit a comment
                                                    Silver Spring, MD 20993–0002, 301–                      Food and Drug Administration                          with confidential information that you
                                                    796–1300.                                                                                                     do not wish to be made available to the
                                                       Registration: Registration is free for               [Docket No. FDA–2016–D–1210]                          public, submit the comment as a
                                                    the public workshop. Interested parties
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                                                                                                                                  written/paper submission and in the
                                                    are encouraged to register early. Seating               Technical Considerations for Additive                 manner detailed (see ‘‘Written/Paper
                                                    will be available on a first-come, first-               Manufactured Devices; Draft Guidance                  Submissions’’ and ‘‘Instructions’’).
                                                    served basis. To register electronically,               for Industry and Food and Drug
                                                    email registration information                          Administration Staff; Availability                    Written/Paper Submissions
                                                    (including name, title, firm name,                      AGENCY:    Food and Drug Administration,                Submit written/paper submissions as
                                                    address, telephone, and fax number) to                  HHS.                                                  follows:
                                                    Malariaworkshop2016@fda.hhs.gov.                                                                                • Mail/Hand delivery/Courier (for
                                                                                                            ACTION:   Notice.
                                                    Persons without access to the Internet                                                                        written/paper submissions): Division of


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                                                                                   Federal Register / Vol. 81, No. 90 / Tuesday, May 10, 2016 / Notices                                            28877

                                                    Dockets Management (HFA–305), Food                      Management, 5630 Fishers Lane, Rm.                    methods for the final finished device, as
                                                    and Drug Administration, 5630 Fishers                   1061, Rockville, MD 20852.                            well as optimal process validation and
                                                    Lane, Rm. 1061, Rockville, MD 20852.                      An electronic copy of the draft                     verification methods for these devices.
                                                       • For written/paper comments                         guidance document is available for                    To discuss these challenges and obtain
                                                    submitted to the Division of Dockets                    download from the Internet. See the                   initial stakeholder input, the FDA held
                                                    Management, FDA will post your                          SUPPLEMENTARY INFORMATION section for                 a public workshop entitled ‘‘Additive
                                                    comment, as well as any attachments,                    information on electronic access to the               Manufacturing of Medical Devices: An
                                                    except for information submitted,                       draft guidance. Submit written requests               Interactive Discussion on the Technical
                                                    marked and identified, as confidential,                 for a single hard copy of the draft                   Considerations of 3D Printing,’’ on
                                                    if submitted as detailed in                             guidance document entitled ‘‘Technical                October 8–9, 2014 (http://www.fda.gov/
                                                    ‘‘Instructions.’’                                       Considerations for Additive                           MedicalDevices/NewsEvents/Workshops
                                                       Instructions: All submissions received               Manufactured Devices’’ to the Office of               Conferences/ucm397324.htm). When
                                                    must include the Docket No. FDA–                        the Center Director, Guidance and                     finalized, this draft guidance document
                                                    2016–D–1210 for ‘‘Technical                             Policy Development, Center for Devices                will recommend technical aspects of an
                                                    Considerations for Additive                             and Radiological Health (CDRH), Food                  additively manufactured device that
                                                    Manufactured Devices.’’ Received                        and Drug Administration, 10903 New                    should be considered through the
                                                    comments will be placed in the docket                   Hampshire Ave., Bldg. 66, Rm. 5431,                   phases of development, production
                                                    and, except for those submitted as                      Silver Spring, MD 20993–0002; or the                  process, process validation, and final
                                                    ‘‘Confidential Submissions,’’ publicly                  Office of Communication, Outreach, and                finished device testing.
                                                    viewable at http://www.regulations.gov                  Development, Center for Biologics                        This draft guidance is a leapfrog
                                                    or at the Division of Dockets                           Evaluation and Research (CBER), Food                  guidance; leapfrog guidances are
                                                    Management between 9 a.m. and 4 p.m.,                   and Drug Administration, 10903 New                    intended to serve as a mechanism by
                                                    Monday through Friday.                                  Hampshire Ave., Bldg. 71, Rm. 3128,                   which the Agency can share initial
                                                       • Confidential Submissions—To                        Silver Spring, MD 20993–0002. Send                    thoughts regarding the content of
                                                    submit a comment with confidential                      one self-addressed adhesive label to                  premarket submissions for emerging
                                                    information that you do not wish to be                  assist that office in processing your                 technologies and new clinical
                                                    made publicly available, submit your                    request.                                              applications that are likely to be of
                                                    comments only as a written/paper                                                                              public health importance very early in
                                                                                                            FOR FURTHER INFORMATION CONTACT:
                                                    submission. You should submit two                                                                             product development. This leapfrog
                                                    copies total. One copy will include the                 Matthew Di Prima, Center for Devices
                                                                                                            and Radiological Health, Food and Drug                guidance represents the Agency’s initial
                                                    information you claim to be confidential                                                                      thinking, and our recommendations
                                                    with a heading or cover note that states                Administration, 10903 New Hampshire
                                                                                                                                                                  may change as more information
                                                    ‘‘THIS DOCUMENT CONTAINS                                Ave., Bldg. 62, Rm. 2214, Silver Spring,
                                                                                                                                                                  becomes available. The Agency strongly
                                                    CONFIDENTIAL INFORMATION.’’ The                         MD 20993–0002, 301–796–2507; or
                                                                                                                                                                  encourages manufacturers to engage
                                                    Agency will review this copy, including                 Stephen Ripley, Center for Biologics
                                                                                                                                                                  with CDRH and/or CBER through the
                                                    the claimed confidential information, in                Evaluation and Research, Food and
                                                                                                                                                                  Pre-Submission process to obtain more
                                                    its consideration of comments. The                      Drug Administration, 10903 New
                                                                                                                                                                  detailed feedback regarding their AM
                                                    second copy, which will have the                        Hampshire Ave., Bldg. 71, Rm. 7301,
                                                                                                                                                                  device or process. For more information
                                                    claimed confidential information                        Silver Spring, MD 20993, 240–402–
                                                                                                                                                                  on Pre-Submissions, please see
                                                    redacted/blacked out, will be available                 7911.
                                                                                                                                                                  ‘‘Requests for Feedback on Medical
                                                    for public viewing and posted on http://                SUPPLEMENTARY INFORMATION:                            Device Submissions: The Pre-
                                                    www.regulations.gov. Submit both                                                                              Submission Program and Meetings with
                                                                                                            I. Background
                                                    copies to the Division of Dockets                                                                             Food and Drug Administration Staff’’
                                                    Management. If you do not wish your                        FDA has developed this draft leapfrog              (http://www.fda.gov/downloads/
                                                    name and contact information to be                      guidance to provide FDA’s initial                     MedicalDevices/DeviceRegulationand
                                                    made publicly available, you can                        thoughts on technical considerations                  Guidance/GuidanceDocuments/UCM3
                                                    provide this information on the cover                   specific to devices using additive                    11176.pdf).
                                                    sheet and not in the body of your                       manufacturing (AM), the broad category
                                                    comments and you must identify this                     of manufacturing encompassing 3D                      II. Significance of Guidance
                                                    information as ‘‘confidential.’’ Any                    printing. In medical device applications,                This draft guidance is being issued
                                                    information marked as ‘‘confidential’’                  AM has the advantage of facilitating the              consistent with FDA’s good guidance
                                                    will not be disclosed except in                         creation of anatomically-matched                      practices regulation (21 CFR 10.115).
                                                    accordance with 21 CFR 10.20 and other                  devices and surgical instrumentation by               The draft guidance, when finalized, will
                                                    applicable disclosure law. For more                     using a patient’s own medical imaging.                represent the current thinking of FDA
                                                    information about FDA’s posting of                      Another advantage is the ease in                      on technical considerations for additive
                                                    comments to public dockets, see 80 FR                   fabricating complex geometric                         manufactured devices. It does not
                                                    56469, September 18, 2015, or access                    structures, allowing the creation of                  establish any rights for any person and
                                                    the information at: http://www.fda.gov/                 engineered open lattice structures,                   is not binding on FDA or the public.
                                                    regulatoryinformation/dockets/                          tortuous internal channels, and internal              You can use an alternative approach if
                                                    default.htm.                                            support structures that would not be                  it satisfies the requirements of the
                                                       Docket: For access to the docket to                  easily possible using traditional (non-
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                                                                                                                                  applicable statutes and regulations.
                                                    read background documents or the                        additive) manufacturing approaches.
                                                    electronic and written/paper comments                   However, the unique aspects of the AM                 III. Electronic Access
                                                    received, go to http://                                 process, such as the layer-wise                          Persons interested in obtaining a copy
                                                    www.regulations.gov and insert the                      fabrication process, and the relative lack            of the draft guidance may do so by
                                                    docket number, found in brackets in the                 of medical device history of devices                  downloading an electronic copy from
                                                    heading of this document, into the                      manufactured using AM techniques,                     the Internet. A search capability for all
                                                    ‘‘Search’’ box and follow the prompts                   pose challenges in determining optimal                CDRH guidance documents is available
                                                    and/or go to the Division of Dockets                    characterization and assessment                       at http://www.fda.gov/MedicalDevices/


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                                                    28878                                     Federal Register / Vol. 81, No. 90 / Tuesday, May 10, 2016 / Notices

                                                    DeviceRegulationandGuidance/                                                 Dated: May 4, 2016.                                                          Million Hearts focuses on aligning the
                                                    GuidanceDocuments/default.htm.                                             Leslie Kux,                                                                 efforts of federal agencies, states,
                                                    Guidance documents are also available                                      Associate Commissioner for Policy.                                          regions, health systems, communities
                                                    at http://www.fda.gov/BiologicsBlood                                       [FR Doc. 2016–10924 Filed 5–9–16; 8:45 am]                                  and individuals towards this common
                                                    Vaccines/GuidanceCompliance                                                BILLING CODE 4164–01–P                                                      goal, ensuring the coordination of
                                                    RegulatoryInformation/default.htm or                                                                                                                   public health, clinical care, and policy
                                                    http://www.regulations.gov. Persons                                                                                                                    approaches to this complex problem.
                                                    unable to download an electronic copy                                      DEPARTMENT OF HEALTH AND                                                    Previous research has shown that
                                                    of ‘‘Technical Considerations for                                          HUMAN SERVICES                                                              collaborative efforts among
                                                    Additive Manufactured Devices’’ may                                                                                                                    organizations with a variety of
                                                                                                                               Office of the Secretary                                                     programming, resources and skill sets
                                                    send an email request to CDRH-
                                                    Guidance@fda.hhs.gov to receive an                                         [Document Identifier: HHS–OS–0990–New–
                                                                                                                                                                                                           result in higher levels of community
                                                    electronic copy of the document. Please                                    30D]                                                                        impact. Integrated efforts to address
                                                    use the document number 1400002 to                                                                                                                     public health issues by involving
                                                    identify the guidance you are                                              Agency Information Collection                                               multiple stakeholders are predicted to
                                                    requesting.                                                                Activities; Submission to OMB for                                           result in better health outcomes than
                                                                                                                               Review and Approval; Public Comment                                         programs that do not use a collaborative
                                                    IV. Paperwork Reduction Act of 1995                                        Request                                                                     approach.
                                                                                                                                                                                                              ASPE is requesting comment on the
                                                      These collections of information are                                     AGENCY:       Office of the Secretary, HHS.                                 burden for this study that is examining
                                                    subject to review by the Office of                                         ACTION:       Notice.                                                       the Million Hearts public-private
                                                    Management and Budget (OMB) under                                                                                                                      partnership network. The goal of
                                                    the Paperwork Reduction Act of 1995                                        SUMMARY:   In compliance with section
                                                                                                                                                                                                           developing this activity is to examine
                                                    (44 U.S.C. 3501–3520). The collections                                     3507(a)(1)(D) of the Paperwork
                                                                                                                                                                                                           the network to identify facilitators and
                                                    of information in 21 CFR part 814,                                         Reduction Act of 1995, the Office of the
                                                                                                                                                                                                           barriers to effective communication and
                                                    subparts B and E are approved under                                        Secretary (OS), Department of Health
                                                                                                                               and Human Services, has submitted an                                        collaboration in addressing large and
                                                    OMB control number 0910–0231; the                                                                                                                      complex public health problems like
                                                    collections of information in 21 CFR                                       Information Collection Request (ICR),
                                                                                                                               described below, to the Office of                                           cardiovascular disease. This project
                                                    part 814, subpart H are approved under                                                                                                                 wants to take the lessons learned from
                                                                                                                               Management and Budget (OMB) for
                                                    OMB control number 0910–0332; the                                                                                                                      this unique and massive collaboration
                                                                                                                               review and approval. The ICR is for a
                                                    collections of information in 21 CFR                                                                                                                   and apply them to other efforts to
                                                                                                                               new collection. Comments submitted
                                                    part 807, subpart E are approved under                                     during the first public review of this ICR                                  improve the health and well-being of
                                                    OMB control number 0910–0120; the                                          will be provided to OMB. OMB will                                           Americans.
                                                    collections of information in 21 CFR                                       accept further comments from the                                            DATES: Comments on the ICR must be
                                                    part 812 are approved under OMB                                            public on this ICR during the review                                        received on or before June 9, 2016.
                                                    control number 0910–0078; the                                              and approval period.
                                                    collections of information in 21 CFR                                                                                                                   ADDRESSES: Submit your comments to
                                                                                                                                 Proposed Project: Million Hearts                                          OIRA_submission@omb.eop.gov or via
                                                    part 820 are approved under OMB                                            Social Network Analysis: Network
                                                    control number 0910–0073; the                                                                                                                          facsimile to (202) 395–5806.
                                                                                                                               Survey—OMB No. 0990–New—Office of
                                                    collections of information in 21 CFR                                       the Assistant Secretary for Planning and                                    FOR FURTHER INFORMATION CONTACT:
                                                    parts 801 and 809 are approved under                                       Evaluation (ASPE).                                                          Information Collection Clearance staff,
                                                    OMB control number 0910–0485; and                                            Abstract: The Office of the Assistant                                     Information.CollectionClearance@
                                                    the collections of information in the                                      Secretary for Planning and Evaluation                                       hhs.gov or (202) 690–6162.
                                                    guidance document entitled ‘‘Requests                                      (ASPE) is requesting approval on a new                                      SUPPLEMENTARY INFORMATION: When
                                                    for Feedback on Medical Device                                             information collection request from the                                     submitting comments or requesting
                                                    Submissions: The Pre-Submission                                            Office of Management and Budget                                             information, please include the
                                                    Program and Meetings with Food and                                         (OMB) for purposes of conducting a                                          Information Collection Request Title
                                                    Drug Administration Staff’’ are                                            study about the Million Hearts Initiative                                   and document identifier HHS–OS–
                                                    approved under OMB control number                                          and its subsequent public-private                                           0990–New–30D for reference.
                                                    0910–0756.                                                                 partner network.                                                              Information Collection Request Title:

                                                                                                                     TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
                                                                                                                                                                                                                                       Average
                                                                                                                                                                                                       Number of re-
                                                                                                                                                                              Number of                                              burden per              Total burden
                                                                                                    Form name                                                                                           sponses per
                                                                                                                                                                             respondents                                              response                  hours
                                                                                                                                                                                                         respondent                   (in hours)

                                                    Million Hearts Network Survey ........................................................................                                    100                            1                   30/60                 50
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                         Total ..........................................................................................................   ........................   ........................   ........................             50



                                                    Darius Taylor,
                                                    Information Collection Clearance Officer.
                                                    [FR Doc. 2016–10953 Filed 5–9–16; 8:45 am]
                                                    BILLING CODE 4150–05–P




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Document Created: 2016-05-10 05:19:00
Document Modified: 2016-05-10 05:19:00
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAlthough you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of 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 August 8, 2016.
ContactMatthew Di Prima, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 62, Rm. 2214, Silver Spring, MD 20993-0002, 301- 796-2507; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.
FR Citation81 FR 28876 

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