82_FR_46043 82 FR 45854 - Marketing Clearance of Diagnostic Ultrasound Systems and Transducers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

82 FR 45854 - Marketing Clearance of Diagnostic Ultrasound Systems and Transducers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 189 (October 2, 2017)

Page Range45854-45856
FR Document2017-21077

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Marketing Clearance of Diagnostic Ultrasound Systems and Transducers; Draft Guidance for Industry and Food and Drug Administration Staff.'' This draft guidance provides detailed information recommended for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers. This draft guidance is not final nor is it in effect at this time.

Federal Register, Volume 82 Issue 189 (Monday, October 2, 2017) 
[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Notices]
[Pages 45854-45856]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-21077]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5372]


Marketing Clearance of Diagnostic Ultrasound Systems and 
Transducers; Draft Guidance for Industry and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``Marketing Clearance 
of Diagnostic Ultrasound Systems and Transducers; Draft Guidance for 
Industry and Food and Drug Administration Staff.'' This draft guidance 
provides detailed information recommended for manufacturers seeking 
marketing clearance of diagnostic ultrasound systems and transducers. 
This draft guidance is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by January 2, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. 
Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because 
your comment will be made public, you are solely responsible for 
ensuring that your comment does not include any confidential 
information that you or a third party may not wish to be posted, such 
as medical information, your or anyone else's Social Security number, 
or confidential business information, such as a manufacturing process. 
Please note that if you include your name, contact information, or 
other information that identifies you in the body of your

[[Page 45855]]

comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2017-D-5372 for ``Marketing Clearance of Diagnostic Ultrasound 
Systems and Transducers; Draft Guidance for Industry and Food and Drug 
Administration Staff.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 draft guidance document entitled 
``Marketing Clearance of Diagnostic Ultrasound Systems and Transducers; 
Draft 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, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Shahram Vaezy, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4227A, Silver Spring, MD 20993-0002, 301-796-6242 
or Keith Wear, Center for Devices and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 62, Rm. 2104, 
Silver Spring, MD 20993-0002, 301-796-2538.

SUPPLEMENTARY INFORMATION: 

I. Background

    When finalized, this draft guidance will provide detailed 
recommendations for manufacturers seeking marketing clearance of 
diagnostic ultrasound systems and transducers. In addition, this draft 
guidance, when final, is intended to supersede FDA's 2008 guidance 
entitled, ``Information for Manufacturers Seeking Marketing Clearance 
of Diagnostic Ultrasound Systems and Transducers,'' regarding FDA's 
approach to the regulation of certain diagnostic ultrasound devices. 
(Ref. 1). In addition to the regulatory approaches outlined in the 2008 
document, additional guidance is provided for deciding when a device 
modification to a diagnostic ultrasound device can be made without the 
need for submission of a new premarket notification (510(k)) 
submission. As before, device sponsors who comply with the applicable 
premarket notification requirements will continue to be exempt from the 
Electronic Product Radiation Control reporting requirements in 21 CFR 
1002.12, for diagnostic ultrasound devices, as described in the notice 
to industry entitled ``Exemption from Reporting under 21 CFR 1002'' 
(dated February 24, 1986) (Ref. 2). When finalized, this draft guidance 
is applicable to diagnostic ultrasound devices under 21 CFR 892.1550 
(Ultrasonic pulsed doppler imaging system), 21 CFR 892.1560 (Ultrasonic 
pulsed echo imaging system), and 21 CFR 892.1570 (Diagnostic ultrasonic 
transducer).

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 ``Diagnostic 
Ultrasound Systems and Transducer 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. This guidance is not subject to 
Executive Order 12866.

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 Center for Devices and Radiological Health guidance 
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at https://www.regulations.gov. Persons 
unable to download an electronic copy of ``Marketing Clearance of 
Diagnostic Ultrasound Systems and Transducers; Draft Guidance for 
Industry and Food and Drug Administration Staff'' may send an email 
request to [email protected] to receive an electronic copy of 
the document. Please use the document number 560 to identify the 
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of

[[Page 45856]]

information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 807, subpart E, have been 
approved under OMB control number 0910-0120, the collections of 
information in 21 CFR part 820 have been approved under OMB control 
number 0910-0073, and the collections of information in 21 CFR part 801 
have been approved under OMB control number 0910-0485. The collections 
of information in 21 CFR parts 1002 and 1010 are approved under OMB 
control number 0910-0025.

V. References

    The following references are on display in the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the Web site address, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

    1. FDA Guidance, ``Information for Manufacturers Seeking 
Marketing Clearance of Diagnostic Ultrasound Systems and 
Transducers.'' Available at: https://www.fda.gov/downloads/UCM070911.pdf.
    2. FDA, ``Information for Industry.'' Available at: https://www.fda.gov/RadiationEmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/ucm115357.htm

    Dated: September 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-21077 Filed 9-29-17; 8:45 am]
 BILLING CODE 4164-01-P

45854 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices www.regulations.gov and insert the radiology. These devices are classified Dated: September 25, 2017. docket number, found in brackets in the as class II devices that are intended to Leslie Kux, heading of this document, into the be used in controlled viewing Associate Commissioner for Policy. ‘‘Search’’ box and follow the prompts conditions to display and view digital [FR Doc. 2017–21078 Filed 9–29–17; 8:45 am] and/or go to the Dockets Management images for primary image interpretation. BILLING CODE 4164–01–P Staff, 5630 Fishers Lane, Rm. 1061, Display devices for diagnostic radiology Rockville, MD 20852. may also be referred to as soft-copy You may submit comments on any displays or medical grade monitors. DEPARTMENT OF HEALTH AND guidance at any time (see 21 CFR HUMAN SERVICES 10.115(g)(5)). II. Significance of Guidance An electronic copy of the guidance This guidance is being issued Food and Drug Administration document is available for download consistent with FDA’s good guidance from the internet. See the [Docket No. FDA–2017–D–5372] practices regulation (21 CFR 10.115). SUPPLEMENTARY INFORMATION section for This guidance represents the current Marketing Clearance of Diagnostic information on electronic access to the thinking of FDA on Display Devices for Ultrasound Systems and Transducers; guidance. Submit written requests for a Draft Guidance for Industry and Food Diagnostic Radiology. It does not single hard copy of the guidance and Drug Administration Staff; establish any rights for any person and document entitled ‘‘Display Devices for Availability is not binding on FDA or the public. Diagnostic Radiology’’ to the Office of You can use an alternative approach if the Center Director, Guidance and AGENCY: Food and Drug Administration, it satisfies the requirements of the Policy Development, Center for Devices HHS. applicable statutes and regulations. This and Radiological Health, Food and Drug ACTION: Notice of availability. guidance is not subject to Executive Administration, 10903 New Hampshire Order 12866. SUMMARY: The Food and Drug Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one self- III. Electronic Access Administration (FDA or Agency) is addressed adhesive label to assist that announcing the availability of the draft office in processing your request. Persons interested in obtaining a copy guidance entitled ‘‘Marketing Clearance FOR FURTHER INFORMATION CONTACT: of the guidance may do so by of Diagnostic Ultrasound Systems and Robert Ochs, Center for Devices and downloading an electronic copy from Transducers; Draft Guidance for Radiological Health, Food and Drug the Internet. A search capability for all Industry and Food and Drug Administration, 10903 New Hampshire Center for Devices and Radiological Administration Staff.’’ This draft Ave., Bldg. 66, Rm. 4308, Silver Spring, Health guidance documents is available guidance provides detailed information MD 20993–0002, 301–796–6661. at https://www.fda.gov/MedicalDevices/ recommended for manufacturers DeviceRegulationandGuidance/ seeking marketing clearance of SUPPLEMENTARY INFORMATION: GuidanceDocuments/default.htm. diagnostic ultrasound systems and I. Background Guidance documents are also available transducers. This draft guidance is not This guidance applies to display at https://www.regulations.gov. Persons final nor is it in effect at this time. devices intended for diagnostic unable to download an electronic copy DATES: Submit either electronic or radiology as identified in Section III of of ‘‘Display Devices for Diagnostic written comments on the draft guidance the guidance and currently classified Radiology’’ may send an email request by January 2, 2018 to ensure that the under 21 CFR 892.2050 as class II to CDRH-Guidance@fda.hhs.gov to Agency considers your comment on this devices according to section 513(a)(1) of receive an electronic copy of the draft guidance before it begins work on the Federal Food, Drug, and Cosmetic document. Please use the document the final version of the guidance. Act (the FD&C Act) (21 U.S.C. number 1500022 to identify the ADDRESSES: You may submit comments 360c(a)(1)) with the assigned product guidance you are requesting. on any guidance at any time as follows: code PGY. This guidance is intended to IV. Paperwork Reduction Act of 1995 assist industry in preparing a 510(k) for Electronic Submissions display devices intended for use in This guidance refers to previously Submit electronic comments in the diagnostic radiology. This guidance approved collections of information following way: provides recommendations for the types found in FDA regulations. These • Federal eRulemaking Portal: of information you should provide in collections of information are subject to https://www.regulations.gov. Follow the your 510(k) submission for display review by the Office of Management and instructions for submitting comments. devices intended for diagnostic Budget (OMB) under the Paperwork Comments submitted electronically, radiology. This information Reduction Act of 1995 (44 U.S.C. 3501– including attachments, to https:// supplements the requirements for a 3520). The collections of information in www.regulations.gov will be posted to 510(k) submission found in 21 CFR 807 21 CFR part 807, subpart E have been the docket unchanged. Because your Subpart E, as well as recommendations approved under OMB control number comment will be made public, you are provided in other FDA guidance 0910–0120; the collections of solely responsible for ensuring that your documents concerning the specific information in 21 CFR part 801 have comment does not include any content of a 510(k) submission. been approved under OMB control confidential information that you or a FDA considered comments on the number 0910–0485; and the collections third party may not wish to be posted, sradovich on DSK3GMQ082PROD with NOTICES draft guidance that appeared in the of information in the guidance entitled such as medical information, your or Federal Register of February 9, 2016 (81 ‘‘Requests for Feedback on Medical anyone else’s Social Security number, or FR 6869). FDA revised the guidance as Device Submissions: The Pre- confidential business information, such appropriate in response to the Submission Program and Meetings with as a manufacturing process. Please note comments. Food and Drug Administration Staff’’ that if you include your name, contact This guidance applies to workstation have been approved under OMB control information, or other information that medical image displays for diagnostic number 0910–0756. identifies you in the body of your VerDate Sep<11>2014 19:01 Sep 29, 2017 Jkt 244001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\02OCN1.SGM 02OCN1

Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 45855 comments, that information will be more information about FDA’s posting approaches outlined in the 2008 posted on https://www.regulations.gov. of comments to public dockets, see 80 document, additional guidance is • If you want to submit a comment FR 56469, September 18, 2015, or access provided for deciding when a device with confidential information that you the information at: https://www.gpo.gov/ modification to a diagnostic ultrasound do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- device can be made without the need for public, submit the comment as a 23389.pdf. submission of a new premarket written/paper submission and in the Docket: For access to the docket to notification (510(k)) submission. As manner detailed (see ‘‘Written/Paper read background documents or the before, device sponsors who comply Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments with the applicable premarket Written/Paper Submissions received, go to https:// notification requirements will continue www.regulations.gov and insert the to be exempt from the Electronic Submit written/paper submissions as docket number, found in brackets in the Product Radiation Control reporting follows: heading of this document, into the requirements in 21 CFR 1002.12, for • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts diagnostic ultrasound devices, as written/paper submissions): Dockets and/or go to the Dockets Management described in the notice to industry Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061, entitled ‘‘Exemption from Reporting Drug Administration, 5630 Fishers Rockville, MD 20852. under 21 CFR 1002’’ (dated February 24, Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any 1986) (Ref. 2). When finalized, this draft • For written/paper comments guidance is applicable to diagnostic guidance at any time (see 21 CFR submitted to the Dockets Management ultrasound devices under 21 CFR 10.115(g)(5)). Staff, FDA will post your comment, as 892.1550 (Ultrasonic pulsed doppler An electronic copy of the guidance well as any attachments, except for imaging system), 21 CFR 892.1560 document is available for download information submitted, marked and (Ultrasonic pulsed echo imaging from the Internet. See the identified, as confidential, if submitted system), and 21 CFR 892.1570 SUPPLEMENTARY INFORMATION section for as detailed in ‘‘Instructions.’’ (Diagnostic ultrasonic transducer). Instructions: All submissions received information on electronic access to the must include the Docket No. FDA– guidance. Submit written requests for a II. Significance of Guidance 2017–D–5372 for ‘‘Marketing Clearance single hard copy of the draft guidance document entitled ‘‘Marketing This draft guidance is being issued of Diagnostic Ultrasound Systems and consistent with FDA’s good guidance Transducers; Draft Guidance for Clearance of Diagnostic Ultrasound Systems and Transducers; Draft practices regulation (21 CFR 10.115). Industry and Food and Drug The draft guidance, when finalized, will Administration Staff.’’ Received Guidance for Industry and Food and Drug Administration Staff’’ to the Office represent the current thinking of FDA comments will be placed in the docket on ‘‘Diagnostic Ultrasound Systems and and, except for those submitted as of the Center Director, Guidance and Policy Development, Center for Devices Transducer Devices.’’ It does not ‘‘Confidential Submissions,’’ publicly establish any rights for any person and viewable at https://www.regulations.gov and Radiological Health, Food and Drug Administration, 10903 New Hampshire is not binding on FDA or the public. or at the Dockets Management Staff You can use an alternative approach if between 9 a.m. and 4 p.m., Monday Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one self- it satisfies the requirements of the through Friday. applicable statutes and regulations. This • Confidential Submissions—To addressed adhesive label to assist that office in processing your request. guidance is not subject to Executive submit a comment with confidential Order 12866. information that you do not wish to be FOR FURTHER INFORMATION CONTACT: made publicly available, submit your Shahram Vaezy, Center for Devices and III. Electronic Access comments only as a written/paper Radiological Health, Food and Drug Persons interested in obtaining a copy submission. You should submit two Administration, 10903 New Hampshire of the draft guidance may do so by copies total. One copy will include the Ave., Bldg. 66, Rm. 4227A, Silver downloading an electronic copy from information you claim to be confidential Spring, MD 20993–0002, 301–796–6242 the Internet. A search capability for all with a heading or cover note that states or Keith Wear, Center for Devices and Center for Devices and Radiological ‘‘THIS DOCUMENT CONTAINS Radiological Health, Food and Drug Health guidance documents is available CONFIDENTIAL INFORMATION.’’ The Administration, 10903 New Hampshire at https://www.fda.gov/MedicalDevices/ Agency will review this copy, including Ave., Bldg. 62, Rm. 2104, Silver Spring, DeviceRegulationandGuidance/ the claimed confidential information, in MD 20993–0002, 301–796–2538. GuidanceDocuments/default.htm. its consideration of comments. The SUPPLEMENTARY INFORMATION: Guidance documents are also available second copy, which will have the at https://www.regulations.gov. Persons claimed confidential information I. Background unable to download an electronic copy redacted/blacked out, will be available When finalized, this draft guidance of ‘‘Marketing Clearance of Diagnostic for public viewing and posted on will provide detailed recommendations Ultrasound Systems and Transducers; https://www.regulations.gov. Submit for manufacturers seeking marketing Draft Guidance for Industry and Food both copies to the Dockets Management clearance of diagnostic ultrasound and Drug Administration Staff’’ may Staff. If you do not wish your name and systems and transducers. In addition, send an email request to CDRH- contact information to be made publicly this draft guidance, when final, is Guidance@fda.hhs.gov to receive an available, you can provide this intended to supersede FDA’s 2008 sradovich on DSK3GMQ082PROD with NOTICES electronic copy of the document. Please information on the cover sheet and not guidance entitled, ‘‘Information for use the document number 560 to in the body of your comments and you Manufacturers Seeking Marketing identify the guidance you are must identify this information as Clearance of Diagnostic Ultrasound requesting. ‘‘confidential.’’ Any information marked Systems and Transducers,’’ regarding as ‘‘confidential’’ will not be disclosed FDA’s approach to the regulation of IV. Paperwork Reduction Act of 1995 except in accordance with 21 CFR 10.20 certain diagnostic ultrasound devices. This draft guidance refers to and other applicable disclosure law. For (Ref. 1). In addition to the regulatory previously approved collections of VerDate Sep<11>2014 19:01 Sep 29, 2017 Jkt 244001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\02OCN1.SGM 02OCN1

45856 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices information found in FDA regulations. Substances and Formulations: Advances solely responsible for ensuring that your These collections of information are in Characterization and In Vitro comment does not include any subject to review by the Office of Testing.’’ The purpose of the workshop confidential information that you or a Management and Budget (OMB) under is to share FDA’s current experiences on third party may not wish to be posted, the Paperwork Reduction Act of 1995 the evaluation and characterization of such as medical information, your or (44 U.S.C. 3501–3520). The collections critical quality attributes for complex anyone else’s Social Security number, or of information in 21 CFR part 807, drug substances (e.g. polymeric and confidential business information, such subpart E, have been approved under naturally derived substances and as a manufacturing process. Please note OMB control number 0910–0120, the peptides) and formulations (e.g. that if you include your name, contact collections of information in 21 CFR liposomes, emulsions, suspensions, and information, or other information that part 820 have been approved under polymeric inserts); discuss current and identifies you in the body of your OMB control number 0910–0073, and future innovative approaches for the comments, that information will be the collections of information in 21 CFR development and regulatory review of posted on https://www.regulations.gov. part 801 have been approved under equivalent complex drug products; • If you want to submit a comment OMB control number 0910–0485. The obtain input from various stakeholders with confidential information that you collections of information in 21 CFR on how to conduct and assess critical do not wish to be made available to the parts 1002 and 1010 are approved under quality attribute measurements to public, submit the comment as a OMB control number 0910–0025. demonstrate equivalence of complex written/paper submission and in the drug products; and request comments manner detailed (see ‘‘Written/Paper V. References Submissions’’ and ‘‘Instructions’’). on these topics. The following references are on DATES: The public workshop will be Written/Paper Submissions display in the Dockets Management held on October 6, 2017, from 8:30 a.m. Staff (see ADDRESSES) and are available Submit written/paper submissions as to 4:30 p.m. Submit either electronic or follows: for viewing by interested persons written comments on this public between 9 a.m. and 4 p.m., Monday • Mail/Hand delivery/Courier (for workshop by November 10, 2017. See written/paper submissions): Dockets through Friday; they are also available the SUPPLEMENTARY INFORMATION section electronically at https:// Management Staff (HFA–305), Food and for registration date and information. Drug Administration, 5630 Fishers www.regulations.gov. FDA has verified ADDRESSES: The public workshop will Lane, Rm. 1061, Rockville, MD 20852. the Web site address, as of the date this be held at FDA White Oak Campus, • For written/paper comments document publishes in the Federal 10903 New Hampshire Ave., Bldg. 31 submitted to the Dockets Management Register, but Web sites are subject to Conference Center, the Great Room (Rm. Staff, FDA will post your comment, as change over time. 1503 B+C), Silver Spring, MD 20993– well as any attachments, except for 1. FDA Guidance, ‘‘Information for 0002. Entrance for the public workshop information submitted, marked and Manufacturers Seeking Marketing Clearance participants (non-FDA employees) is identified, as confidential, if submitted of Diagnostic Ultrasound Systems and through Building 1 where routine as detailed in ‘‘Instructions.’’ Transducers.’’ Available at: https:// security check procedures will be Instructions: All submissions received www.fda.gov/downloads/UCM070911.pdf. 2. FDA, ‘‘Information for Industry.’’ performed. For parking and security must include the Docket No. FDA– Available at: https://www.fda.gov/ information, please refer to https:// 2017–N–5776 for ‘‘Demonstrating RadiationEmittingProducts/Radiation www.fda.gov/AboutFDA/Working Equivalence of Generic Complex Drug EmittingProductsandProcedures/Medical atFDA/BuildingsandFacilities/WhiteOak Substances and Formulations: Advances Imaging/ucm115357.htm CampusInformation/ucm241740.htm. in Characterization and In Vitro Dated: September 22, 2017. You may submit comments as Testing.’’ Received comments, those Leslie Kux, follows. Please note that late, untimely filed in a timely manner (see filed comments will not be considered. ADDRESSES), will be placed in the docket Associate Commissioner for Policy. Electronic comments must be submitted and, except for those submitted as [FR Doc. 2017–21077 Filed 9–29–17; 8:45 am] on or before November 10, 2017. The ‘‘Confidential Submissions,’’ publicly BILLING CODE 4164–01–P https://www.regulations.gov electronic viewable at https://www.regulations.gov filing system will accept comments or at the Dockets Management Staff until midnight Eastern Time at the end between 9 a.m. and 4 p.m., Monday DEPARTMENT OF HEALTH AND of November 10, 2017. Comments through Friday. HUMAN SERVICES • Confidential Submissions—To received by mail/hand delivery/courier Food and Drug Administration (for written/paper submissions) will be submit a comment with confidential considered timely if they are information that you do not wish to be [Docket No. FDA–2017–N–5776] postmarked or the delivery service made publicly available, submit your acceptance receipt is on or before that comments only as a written/paper Equivalence of Complex Products; submission. You should submit two date. Public Workshop; Request for copies total. One copy will include the Comments Electronic Submissions information you claim to be confidential AGENCY: Food and Drug Administration, Submit electronic comments in the with a heading or cover note that states HHS. following way: ‘‘THIS DOCUMENT CONTAINS • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The sradovich on DSK3GMQ082PROD with NOTICES ACTION: Notice of public workshop; request for comments. https://www.regulations.gov. Follow the Agency will review this copy, including instructions for submitting comments. the claimed confidential information, in SUMMARY: The Food and Drug Comments submitted electronically, its consideration of comments. The Administration (FDA, the Agency, or including attachments, to https:// second copy, which will have the we) is announcing the following public www.regulations.gov will be posted to claimed confidential information workshop entitled ‘‘Demonstrating the docket unchanged. Because your redacted/blacked out, will be available Equivalence of Generic Complex Drug comment will be made public, you are for public viewing and posted on VerDate Sep<11>2014 19:01 Sep 29, 2017 Jkt 244001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\02OCN1.SGM 02OCN1


Document Created: 2017-09-30 04:40:36
Document Modified: 2017-09-30 04:40:36
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 of availability.
DatesSubmit either electronic or written comments on the draft guidance by January 2, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
ContactShahram Vaezy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4227A, Silver Spring, MD 20993-0002, 301-796-6242 or Keith Wear, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 62, Rm. 2104, Silver Spring, MD 20993-0002, 301-796-2538.
FR Citation82 FR 45854 
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