83_FR_41238 83 FR 41078 - Process To Request a Review of Food and Drug Administration's Decision Not To Issue Certain Export Certificates for Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

83 FR 41078 - Process To Request a Review of Food and Drug Administration's Decision Not To Issue Certain Export Certificates for Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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 83, Issue 160 (August 17, 2018)

Page Range41078-41079
FR Document2018-17796

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices; Draft Guidance for Industry and Food and Drug Administration Staff.'' FDA is issuing this draft guidance to comply with changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the FDA Reauthorization Act of 2017 (FDARA), to specify the process afforded to persons denied a Certificate to Foreign Government (CFG) for a device. This draft guidance describes the information that the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) will provide to a person whose request for a CFG for a device is denied, and the process for seeking review of such a denial. This draft guidance is not final nor is it in effect at this time.

Federal Register, Volume 83 Issue 160 (Friday, August 17, 2018) 
[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)]
[Notices]
[Pages 41078-41079]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-17796]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2310]


Process To Request a Review of Food and Drug Administration's 
Decision Not To Issue Certain Export Certificates for Devices; Draft 
Guidance for Industry and Food and Drug Administration Staff; 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the availability of the draft guidance entitled ``Process to Request a 
Review of FDA's Decision Not to Issue Certain Export Certificates for 
Devices; Draft Guidance for Industry and Food and Drug Administration 
Staff.'' FDA is issuing this draft guidance to comply with changes to 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the 
FDA Reauthorization Act of 2017 (FDARA), to specify the process 
afforded to persons denied a Certificate to Foreign Government (CFG) 
for a device. This draft guidance describes the information that the 
Center for Devices and Radiological Health (CDRH) and the Center for 
Biologics Evaluation and Research (CBER) will provide to a person whose 
request for a CFG for a device is denied, and the process for seeking 
review of such a denial. 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 October 16, 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 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-2018-D-2310 for ``Process to Request a Review of FDA's Decision Not 
to Issue Certain Export Certificates for Devices; 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

[[Page 41079]]

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 entitled 
``Process to Request a Review of FDA's Decision Not to Issue Certain 
Export Certificates for Devices; 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 or the Office of 
Communication, Outreach, and Development, Center for Biologics 
Evaluation and Research, 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: Joann Belt, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 3658, Silver Spring, MD 20993-0002, 
exportcert@cdrh.fda.gov, 301-796-7400, option 3; 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 is issuing this draft guidance to comply with section 704 of 
FDARA (Pub. L. 115-52), which amended section 801 of the FD&C Act, to 
specify the process afforded to persons denied a CFG for a device. This 
draft guidance describes the information that CDRH and CBER will 
provide to a person whose request for a CFG for a device is denied, and 
the process for seeking review of such a denial. This draft guidance 
applies to the process for persons denied CFGs requested pursuant to 
section 801(e)(4)(A) of the FD&C Act (21 U.S.C. 381(e)(4)(A) for 
devices manufactured in an establishment registered under section 510 
of the FD&C Act (21 U.S.C. 360) (i.e., FDA-approved, cleared, or 
exempted devices) that are exported from the United States. This draft 
guidance supplements the FDA's guidance ``FDA Export Certificates,'' 
which is available at: https://www.fda.gov/RegulatoryInformation/Guidances/ucm125789.htm. This draft guidance is not final nor is it in 
effect at this time.

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 the process 
for persons denied a certificate to foreign government for a device. 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 CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This guidance document is also available 
at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download an electronic copy of 
``Process to Request a Review of FDA's Decision Not to Issue Certain 
Export Certificates for Devices; Draft Guidance for Industry and Food 
and Drug Administration Staff'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. 
Please use the document number 17044 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information. 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 
sections 801(e) and 802 (21 U.S.C. 382) of the FD&C Act have been 
approved under OMB control number 0910-0498; the collections of 
information in 21 CFR part 807, subparts A through E, have been 
approved under OMB control number 0910-0625; the collections of 
information in 21 CFR part 820 have been approved under OMB control 
number 0910-0073; and the collections of information in the guidance 
``Center for Devices and Radiological Health Appeals Processes'' have 
been approved under OMB control number 0910-0738.

    Dated: August 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17796 Filed 8-16-18; 8:45 am]
BILLING CODE 4164-01-P

41078 Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Notices information. No comments were We estimate the burden of the received. information collection as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Total Average Number of Total Submission of controlled correspondence responses per annual burden per respondents hours respondent responses response Generic drug manufacturers, related industry, and rep- resentatives ...................................................................... 390 3.8 1,496 5 7,480 1 There are no capital costs or operating and maintenance costs associated with this collection of information. This is the first extension of the DEPARTMENT OF HEALTH AND instructions for submitting comments. information collection. We base our HUMAN SERVICES Comments submitted electronically, estimate on a review of Agency data of including attachments, to https:// Fiscal Year submissions for 2014, 2015, Food and Drug Administration www.regulations.gov will be posted to and 2016, which reflects an increase in [Docket No. FDA–2018–D–2310] the docket unchanged. Because your submissions that we attribute to an comment will be made public, you are increase in generic drug development. Process To Request a Review of Food solely responsible for ensuring that your Accordingly, we estimate 390 generic and Drug Administration’s Decision comment does not include any drug manufacturers and related industry Not To Issue Certain Export confidential information that you or a (e.g., contract research organizations Certificates for Devices; Draft third party may not wish to be posted, conducting bioanalytical or Guidance for Industry and Food and such as medical information, your or bioequivalence clinical trials) or their Drug Administration Staff; Availability anyone else’s Social Security number, or confidential business information, such representatives will each submit an AGENCY: Food and Drug Administration, as a manufacturing process. Please note average of 3.8 inquiries annually for a HHS. that if you include your name, contact total of 1,496 inquiries [1,496 ÷ 390 = ACTION: Notice of availability. information, or other information that 3.8]. Information submitted with each identifies you in the body of your inquiry varies widely in content, SUMMARY: The Food and Drug Administration (FDA or Agency) is comments, that information will be depending on the complexity of the posted on https://www.regulations.gov. request. Inquiries that are defined as announcing the availability of the draft guidance entitled ‘‘Process to Request a • If you want to submit a comment controlled correspondence may range with confidential information that you Review of FDA’s Decision Not to Issue from a simple inquiry on generic drug Certain Export Certificates for Devices; do not wish to be made available to the labeling to a more complex inquiry for Draft Guidance for Industry and Food public, submit the comment as a a formulation assessment for a specific and Drug Administration Staff.’’ FDA is written/paper submission and in the proposed generic drug product. As a issuing this draft guidance to comply manner detailed (see ‘‘Written/Paper result, these inquiries can vary between with changes to the Federal Food, Drug, Submissions’’ and ‘‘Instructions’’). 1 and 10 burden hours. and Cosmetic Act (FD&C Act) as Written/Paper Submissions Because the content of inquiries amended by the FDA Reauthorization considered controlled correspondence is Act of 2017 (FDARA), to specify the Submit written/paper submissions as widely varied, we are providing an process afforded to persons denied a follows: Certificate to Foreign Government (CFG) • Mail/Hand delivery/Courier (for average burden hour for each inquiry. for a device. This draft guidance written/paper submissions): Dockets We estimate that it will take an average describes the information that the Management Staff (HFA–305), Food and of 5 hours per inquiry for industry to Center for Devices and Radiological Drug Administration, 5630 Fishers gather necessary information, prepare Lane, Rm. 1061, Rockville, MD 20852. Health (CDRH) and the Center for the request, and submit the request to • For written/paper comments Biologics Evaluation and Research FDA. As a result, we estimate that it will (CBER) will provide to a person whose submitted to the Dockets Management take an average of 7,480 hours annually request for a CFG for a device is denied, Staff, FDA will post your comment, as for industry to prepare and submit and the process for seeking review of well as any attachments, except for inquiries considered controlled such a denial. This draft guidance is not information submitted, marked and correspondence. final nor is it in effect at this time. identified, as confidential, if submitted Dated: August 10, 2018. DATES: Submit either electronic or as detailed in ‘‘Instructions.’’ Leslie Kux, written comments on the draft guidance Instructions: All submissions received by October 16, 2018 to ensure that the must include the Docket No. FDA– Associate Commissioner for Policy. Agency considers your comment on this 2018–D–2310 for ‘‘Process to Request a [FR Doc. 2018–17787 Filed 8–16–18; 8:45 am] draft guidance before it begins work on Review of FDA’s Decision Not to Issue BILLING CODE 4164–01–P the final version of the guidance. Certain Export Certificates for Devices; ADDRESSES: You may submit comments Draft Guidance for Industry and Food amozie on DSK3GDR082PROD with NOTICES1 on any guidance at any time as follows: and Drug Administration Staff.’’ Received comments will be placed in Electronic Submissions the docket and, except for those Submit electronic comments in the submitted as ‘‘Confidential following way: Submissions,’’ publicly viewable at • Federal eRulemaking Portal: https://www.regulations.gov or at the https://www.regulations.gov. Follow the Dockets Management Staff between 9 VerDate Sep<11>2014 17:17 Aug 16, 2018 Jkt 244001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\17AUN1.SGM 17AUN1

Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Notices 41079 a.m. and 4 p.m., Monday through and Policy Development, Center for on the process for persons denied a Friday. Devices and Radiological Health, Food certificate to foreign government for a • Confidential Submissions—To and Drug Administration, 10903 New device. It does not establish any rights submit a comment with confidential Hampshire Ave., Bldg. 66, Rm. 5431, for any person and is not binding on information that you do not wish to be Silver Spring, MD 20993–0002 or the FDA or the public. You can use an made publicly available, submit your Office of Communication, Outreach, and alternative approach if it satisfies the comments only as a written/paper Development, Center for Biologics requirements of the applicable statutes submission. You should submit two Evaluation and Research, Food and and regulations. This guidance is not copies total. One copy will include the Drug Administration, 10903 New subject to Executive Order 12866. information you claim to be confidential Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send III. Electronic Access with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS one self-addressed adhesive label to Persons interested in obtaining a copy CONFIDENTIAL INFORMATION.’’ The assist that office in processing your of the draft guidance may do so by Agency will review this copy, including request. downloading an electronic copy from the claimed confidential information, in FOR FURTHER INFORMATION CONTACT: the internet. A search capability for all its consideration of comments. The Joann Belt, Center for Devices and CDRH guidance documents is available second copy, which will have the Radiological Health, Food and Drug at https://www.fda.gov/MedicalDevices/ claimed confidential information Administration, 10903 New Hampshire DeviceRegulationandGuidance/ redacted/blacked out, will be available Ave., Bldg. 66, Rm. 3658, Silver Spring, GuidanceDocuments/default.htm. This for public viewing and posted on MD 20993–0002, exportcert@ guidance document is also available at https://www.regulations.gov. Submit cdrh.fda.gov, 301–796–7400, option 3; https://www.fda.gov/BiologicsBlood both copies to the Dockets Management or Stephen Ripley, Center for Biologics Vaccines/GuidanceCompliance Staff. If you do not wish your name and Evaluation and Research, Food and RegulatoryInformation/default.htm or contact information to be made publicly Drug Administration, 10903 New https://www.regulations.gov. Persons available, you can provide this Hampshire Ave., Bldg. 71, Rm. 7301, unable to download an electronic copy information on the cover sheet and not Silver Spring, MD 20993, 240–402– of ‘‘Process to Request a Review of in the body of your comments and you 7911. FDA’s Decision Not to Issue Certain must identify this information as Export Certificates for Devices; Draft SUPPLEMENTARY INFORMATION: ‘‘confidential.’’ Any information marked Guidance for Industry and Food and as ‘‘confidential’’ will not be disclosed I. Background Drug Administration Staff’’ may send an except in accordance with 21 CFR 10.20 FDA is issuing this draft guidance to email request to CDRH-Guidance@ and other applicable disclosure law. For comply with section 704 of FDARA fda.hhs.gov to receive an electronic more information about FDA’s posting (Pub. L. 115–52), which amended copy of the document. Please use the of comments to public dockets, see 80 section 801 of the FD&C Act, to specify document number 17044 to identify the FR 56469, September 18, 2015, or access the process afforded to persons denied guidance you are requesting. the information at: https://www.gpo.gov/ a CFG for a device. This draft guidance fdsys/pkg/FR-2015-09-18/pdf/2015- IV. Paperwork Reduction Act of 1995 describes the information that CDRH 23389.pdf. and CBER will provide to a person This draft guidance refers to Docket: For access to the docket to whose request for a CFG for a device is previously approved collections of read background documents or the denied, and the process for seeking information. These collections of electronic and written/paper comments review of such a denial. This draft information are subject to review by the received, go to https:// guidance applies to the process for Office of Management and Budget www.regulations.gov and insert the persons denied CFGs requested (OMB) under the Paperwork Reduction docket number, found in brackets in the pursuant to section 801(e)(4)(A) of the Act of 1995 (44 U.S.C. 3501–3520). The heading of this document, into the FD&C Act (21 U.S.C. 381(e)(4)(A) for collections of information in sections ‘‘Search’’ box and follow the prompts devices manufactured in an 801(e) and 802 (21 U.S.C. 382) of the and/or go to the Dockets Management establishment registered under section FD&C Act have been approved under Staff, 5630 Fishers Lane, Rm. 1061, 510 of the FD&C Act (21 U.S.C. 360) OMB control number 0910–0498; the Rockville, MD 20852. (i.e., FDA-approved, cleared, or collections of information in 21 CFR You may submit comments on any exempted devices) that are exported part 807, subparts A through E, have guidance at any time (see 21 CFR from the United States. This draft been approved under OMB control 10.115(g)(5)). guidance supplements the FDA’s number 0910–0625; the collections of An electronic copy of the guidance guidance ‘‘FDA Export Certificates,’’ information in 21 CFR part 820 have document is available for download which is available at: https:// been approved under OMB control from the internet. See the www.fda.gov/RegulatoryInformation/ number 0910–0073; and the collections SUPPLEMENTARY INFORMATION section for Guidances/ucm125789.htm. This draft of information in the guidance ‘‘Center information on electronic access to the guidance is not final nor is it in effect for Devices and Radiological Health guidance. Submit written requests for a at this time. Appeals Processes’’ have been approved single hard copy of the draft guidance under OMB control number 0910–0738. entitled ‘‘Process to Request a Review of II. Significance of Guidance amozie on DSK3GDR082PROD with NOTICES1 Dated: August 13, 2018. FDA’s Decision Not to Issue Certain This draft guidance is being issued Export Certificates for Devices; Draft consistent with FDA’s good guidance Leslie Kux, Guidance for Industry and Food and practices regulation (21 CFR 10.115). Associate Commissioner for Policy. Drug Administration Staff ’’ to the The draft guidance, when finalized, will [FR Doc. 2018–17796 Filed 8–16–18; 8:45 am] Office of the Center Director, Guidance represent the current thinking of FDA BILLING CODE 4164–01–P VerDate Sep<11>2014 17:17 Aug 16, 2018 Jkt 244001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\17AUN1.SGM 17AUN1


Document Created: 2018-08-17 03:25:41
Document Modified: 2018-08-17 03:25:41
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 October 16, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
ContactJoann Belt, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3658, Silver Spring, MD 20993-0002, [email protected], 301-796-7400, option 3; 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 Citation83 FR 41078 
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