Process To Request a Review of Food and Drug Administration's Decision Not To Issue Certain Export Certificates for Devices; Guidance for Industry and Food and Drug Administration Staff; Availability, 61913-61915 [2019-24717]

Download as PDF Federal Register / Vol. 84, No. 220 / Thursday, November 14, 2019 / Notices khammond on DSKJM1Z7X2PROD with NOTICES Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6304, Silver Spring, MD 20993–0002, 240– 402–6525, Fax: 301–847–8443, meghana.chalasani@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background This public workshop is intended to support FDA implementation of requirements for guidance development under section 3002 of the Cures Act (Pub. L. 114–255) and to meet a performance goal included in PDUFA VI. Section 3002 of Title III, Subtitle A of the Cures Act directs FDA to develop patient-focused drug development guidance to address a number of areas, including methodologies, standards, and technologies to collect and analyze COA data for purposes of regulatory decision-making. In addition, FDA committed to meet certain performance goals under PDUFA VI. This reauthorization, part of the FDA Reauthorization Act of 2017 (Pub. L. 115–52), signed by President Trump on August 18, 2017, includes a number of performance goals and procedures that are documented in the PDUFA VI Commitment Letter, which is available at https://www.fda.gov/downloads/ ForIndustry/UserFees/PrescriptionDrug UserFee/UCM511438.pdf. These goal commitments were developed in consultation with patient and consumer advocates, healthcare professionals, and other public stakeholders, as part of negotiations with regulated industry. Section J.1 of the commitment letter, ‘‘Enhancing the Incorporation of the Patient’s Voice in Drug Development and DecisionMaking,’’ (https://www.fda.gov/ downloads/ForIndustry/UserFees/ PrescriptionDrugUserFee/ UCM511438.pdf) outlines work, including the development of a series of guidance documents and associated public workshops to facilitate the advancement and use of systematic approaches to collect and utilize robust and meaningful patient and caregiver input that can more consistently inform drug development, and, as appropriate, regulatory decision making. Prior to the issuance of each guidance, as part of the development, FDA will conduct a public workshop to gather input from the wider community of patients, patient advocates, academic researchers, expert practitioners, drug developers, and other stakeholders. II. Topics for Discussion at the Public Workshop During the public workshop, speakers and participants will address a range of issues and considerations related to VerDate Sep<11>2014 17:47 Nov 13, 2019 Jkt 250001 incorporating COAs into endpoints for regulatory decision-making. The range of issues and considerations includes: (1) Endpoint development; (2) estimands and analysis models; (3) addressing heterogeneity in disease symptoms and functional status between patients and within the same patient over time; and (4) data collection, storage, transmission, and analysis. III. Participating in the Public Workshop Registration: Interested parties are encouraged to register early. To register electronically, please visit https:// patientfocuseddrug development.eventbrite.com. Registration for in-person attendance will close on December 3, 2019. Registration for the webcast will remain open until the day of the workshop. Persons without access to the internet can call 301–796–0621 to register. If you are unable to attend the workshop in person, you can register to view a live webcast of the workshop. You will be asked to indicate in your registration if you plan to attend in person or via the webcast. Seating will be limited, so early registration is recommended. Registration is free. FDA may limit the number of participants from each organization based on space limitations. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the workshop will be based on space availability. If you need special accommodations due to a disability, please contact Meghana Chalasani (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the workshop. Requests for Oral Presentations: There will be time allotted during the workshop for open public comment. Sign-up for this session will be on a first-come, first-served basis on the day of the workshop. Individuals and organizations with common interests are urged to consolidate or coordinate, and request time for a joint presentation. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. Streaming Webcast of the Public Workshop: This public workshop will also be webcast at https:// collaboration.fda.gov/pfddg123119/. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/ help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/ go/connectpro_overview. FDA has verified the website addresses in this document, as of the date this document PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 61913 publishes in the Federal Register, but websites are subject to change over time. Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https:// www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available on the internet at https://www.fda.gov/drugs/news-eventshuman-drugs/patient-focused-drugdevelopment-guidance-collection-andanalysis-clinical-outcome-assessmentdata. Dated: November 8, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–24726 Filed 11–13–19; 8:45 am] BILLING CODE 4164–01–P 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; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ‘‘Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices.’’ FDA is issuing this 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), which specifies the process afforded to persons denied a Certificate to Foreign Government (CFG) for a device. This guidance describes the information that the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), in collaboration with the Office of Regulatory Affairs (ORA), 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. DATES: The announcement of the guidance is published in the Federal Register on November 14, 2019. ADDRESSES: You may submit either electronic or written comments on SUMMARY: E:\FR\FM\14NON1.SGM 14NON1 61914 Federal Register / Vol. 84, No. 220 / Thursday, November 14, 2019 / Notices Agency guidances at any time as follows: khammond on DSKJM1Z7X2PROD with NOTICES 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.’’ 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 VerDate Sep<11>2014 17:47 Nov 13, 2019 Jkt 250001 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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 guidance document entitled ‘‘Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices’’ to the Office of Policy, 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 to 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. PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 FOR FURTHER INFORMATION CONTACT: Joann Belt, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1463, 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 guidance to comply with section 704 of FDARA (Pub. L. 115–52), which amended section 801(e)(4) of the FD&C Act (21 U.S.C. 381(e)(4)), to specify the process afforded to persons denied a CFG for a device. This guidance describes the information that CDRH and CBER, in collaboration with ORA, 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 guidance applies to the process for persons denied CFGs requested pursuant to section 801(e)(4)(A) of the FD&C Act 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 guidance supplements the FDA’s guidance ‘‘FDA Export Certificates,’’ which is available at: https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/fda-export-certificates. FDA considered comments received on the draft guidance that appeared in the Federal Register of August 17, 2018 (83 FR 41078). FDA revised the guidance as appropriate in response to the comments. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for 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 guidance may do so by downloading an electronic copy from the internet. A search capability for all E:\FR\FM\14NON1.SGM 14NON1 Federal Register / Vol. 84, No. 220 / Thursday, November 14, 2019 / Notices Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. This guidance document is also available at https://www.regulations.gov or https:// www.fda.gov/vaccines-blood-biologics/ guidance-compliance-regulatoryinformation-biologics/biologicsguidances. 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’’ 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 guidance refers to previously approved collections of information. OMB control No. Topic FD&C Act sections 801(e) and 802 (21 U.S.C. 382) ................. 21 CFR part 820 ......................................................................... Export certificates for FDA regulated products .......................... Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation. Electronic Submission of Medical Device Registration and Listing. Appeals process ......................................................................... 21 CFR part 807, subparts A through E .................................... ‘‘Center for Devices and Radiological Health Appeals Processes‘‘. [FR Doc. 2019–24717 Filed 11–13–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Standardized Work Plan (SWP) Form for Use With Applications to the Bureau of Health Workforce (BHW) Research and Training Grants and Cooperative Agreements, OMB No. 0906–xxxx–New Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR have been provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA’s ICR only after the 30-day comment period for this Notice has closed. DATES: Comments on this ICR should be received no later than December 16, 2019. SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES 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. 3501–3521). The collections of information in the following FDA regulations and guidance have been approved by OMB as listed in the following table: FD&C Act section; 21 CFR part; or guidance Dated: November 5, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. VerDate Sep<11>2014 17:47 Nov 13, 2019 Jkt 250001 61915 Submit your comments, including the ICR Title, to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to (202) 395–5806. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443– 1984. SUPPLEMENTARY INFORMATION: Information Collection Request Title: SWP Form for Use with Applications to BHW Research and Training Grants and Cooperative Agreements, OMB No. 0906–xxxx–NEW Abstract: BHW requires applicants for training and research grants and cooperative agreements to submit a work plan that describes the timeframes and deliverables required during the grant period of performance to address each of the needs detailed in the Purpose and Need section of the application, as required in the Notice of Funding Opportunity announcement. Applicants are currently able to submit work plans in a non-standardized format. In order to standardize the data provided by applicants to make informed decisions about funding and assist with monitoring awardee progress, BHW plans to require applicants to complete a SWP form in lieu of submitting a work plan in the applicant’s own format. Applicants will use the SWP form when they submit their proposals, and grantees and Project Officers will use the SWP information to assist in monitoring progress once HRSA makes the awards. ADDRESSES: PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 0910–0498 0910–0073 0910–0625 0910–0738 A 60-day notice was published in the Federal Register on June 19, 2019, Vol. 84, No. 118, pp.28560–28561. There was one public comment and it was thoroughly addressed. Need and Proposed Use of the Information: The information collected by the SWP form is necessary to standardize and streamline the data used by HRSA in reviewing applications and monitoring awardees. The form will ask applicants to provide a description of the activities or steps the recipient will take to achieve each of the objectives proposed during the entire period of performance. The current variation in formats and data submitted by applicants reduces efficiency in reviewing, awarding, and monitoring each project, so this change will remedy that inefficiency. In addition, seeking OMB approval comports with the regulatory requirement imposed by 45 CFR 75.206(a), Paperwork clearances. The proposed SWP form will be used to provide information to assess applications for awards including ranking applications as part of the grant review process. BHW will also use the information to assess whether current recipients of grant funding have met statutory and programmatic requirements. Likely Respondents: Respondents will be applicants to HRSA’s research and training programs in BHW. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose E:\FR\FM\14NON1.SGM 14NON1

Agencies

[Federal Register Volume 84, Number 220 (Thursday, November 14, 2019)]
[Notices]
[Pages 61913-61915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24717]


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

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; Guidance 
for Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Process to Request a 
Review of FDA's Decision Not to Issue Certain Export Certificates for 
Devices.'' FDA is issuing this 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), which specifies the process 
afforded to persons denied a Certificate to Foreign Government (CFG) 
for a device. This guidance describes the information that the Center 
for Devices and Radiological Health (CDRH) and the Center for Biologics 
Evaluation and Research (CBER), in collaboration with the Office of 
Regulatory Affairs (ORA), 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.

DATES: The announcement of the guidance is published in the Federal 
Register on November 14, 2019.

ADDRESSES: You may submit either electronic or written comments on

[[Page 61914]]

Agency guidances 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.'' 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.gpo.gov/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 guidance document entitled 
``Process to Request a Review of FDA's Decision Not to Issue Certain 
Export Certificates for Devices'' to the Office of Policy, 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 to 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: Joann Belt, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1463, 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.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is issuing this guidance to comply with section 704 of FDARA 
(Pub. L. 115-52), which amended section 801(e)(4) of the FD&C Act (21 
U.S.C. 381(e)(4)), to specify the process afforded to persons denied a 
CFG for a device. This guidance describes the information that CDRH and 
CBER, in collaboration with ORA, 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 guidance applies to the process for persons denied 
CFGs requested pursuant to section 801(e)(4)(A) of the FD&C Act 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 
guidance supplements the FDA's guidance ``FDA Export Certificates,'' 
which is available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-export-certificates. FDA considered 
comments received on the draft guidance that appeared in the Federal 
Register of August 17, 2018 (83 FR 41078). FDA revised the guidance as 
appropriate in response to the comments.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Process to Request a Review of FDA's 
Decision Not to Issue Certain Export Certificates for 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 guidance may do so by 
downloading an electronic copy from the internet. A search capability 
for all

[[Page 61915]]

Center for Devices and Radiological Health guidance documents is 
available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This 
guidance document is also available at https://www.regulations.gov or 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. 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'' may 
send an email request to [email protected] 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 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. 3501-3521). The collections of information in 
the following FDA regulations and guidance have been approved by OMB as 
listed in the following table:

------------------------------------------------------------------------
 FD&C Act section; 21 CFR part; or                          OMB control
             guidance                       Topic               No.
------------------------------------------------------------------------
FD&C Act sections 801(e) and 802    Export certificates        0910-0498
 (21 U.S.C. 382).                    for FDA regulated
                                     products.
21 CFR part 820...................  Current Good               0910-0073
                                     Manufacturing
                                     Practice (CGMP);
                                     Quality System (QS)
                                     Regulation.
21 CFR part 807, subparts A         Electronic                 0910-0625
 through E.                          Submission of
                                     Medical Device
                                     Registration and
                                     Listing.
``Center for Devices and            Appeals process.....       0910-0738
 Radiological Health Appeals
 Processes``.
------------------------------------------------------------------------


    Dated: November 5, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24717 Filed 11-13-19; 8:45 am]
 BILLING CODE 4164-01-P
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