83 FR 50109 - Process To Request a Review of the Food and Drug Administration's Decision Not To Issue Certain Export Certificates for Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 193 (October 4, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 193 (October 4, 2018)
| Page Range | 50109-50110 | |
| FR Document | 2018-21597 |
[Federal Register Volume 83, Number 193 (Thursday, October 4, 2018)] [Notices] [Pages 50109-50110] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21597] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-2310] Process To Request a Review of the Food and Drug Administration's Decision Not To Issue Certain Export Certificates for Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; extension of comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of August 17, 2018. FDA requested comments on the draft guidance for industry and FDA staff entitled ``Process To Request a Review of FDA's Decision Not To Issue Certain Export Certificates for Devices.'' The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the document published August 17, 2018 (83 FR 41078). Submit either electronic or written comments on the draft guidance by November 15, 2018, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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 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 [[Page 50110]] 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 ``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, [email protected], 301-796-6836; 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 In the Federal Register of August 17, 2018, FDA published a notice of availability with a 60-day comment period to request comments on the draft guidance for industry and FDA staff entitled ``Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices.'' The Agency has received a request for a 30-day extension of the comment period. The request conveyed concern that the current 60-day comment period does not allow sufficient time to develop a meaningful or thoughtful response. FDA has considered the request and is extending the comment period for the notice of availability for 30 days, until November 15, 2018. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying guidance on these important issues. 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 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. 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. 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 [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 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 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 381(e) and 382) 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: September 28, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-21597 Filed 10-3-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 193 / Thursday, October 4, 2018 / Notices 50109
1998, and 1988, and has withdrawn DEPARTMENT OF HEALTH AND • If you want to submit a comment
fourteen guidance documents in HUMAN SERVICES with confidential information that you
response to comments received and do not wish to be made available to the
because these guidance documents were Food and Drug Administration public, submit the comment as a
determined to no longer represent the [Docket No. FDA–2018–D–2310] written/paper submission and in the
Agency’s current thinking. One manner detailed (see ‘‘Written/Paper
guidance has been revised and issued as Process To Request a Review of the Submissions’’ and ‘‘Instructions’’).
a draft guidance, and the revision of Food and Drug Administration’s Written/Paper Submissions
several guidance documents is also Decision Not To Issue Certain Export
being considered as resources permit. Certificates for Devices; Draft Submit written/paper submissions as
Guidance for Industry and Food and follows:
Consistent with the Good Guidance • Mail/Hand Delivery/Courier (for
Practices regulation at 21 CFR Drug Administration Staff; Availability;
Extension of Comment Period written/paper submissions): Dockets
10.115(f)(4), CDRH would appreciate Management Staff (HFA–305), Food and
suggestions that CDRH revise or AGENCY: Food and Drug Administration, Drug Administration, 5630 Fishers
withdraw an already existing guidance HHS. Lane, Rm. 1061, Rockville, MD 20852.
document. We request that the • For written/paper comments
ACTION:Notice of availability; extension
suggestion clearly explain why the submitted to the Dockets Management
of comment period.
guidance document should be revised or Staff, FDA will post your comment, as
withdrawn and, if applicable, how it SUMMARY: The Food and Drug well as any attachments, except for
should be revised. While we are Administration (FDA or the Agency) is information submitted, marked and
requesting feedback on the list of extending the comment period for the identified, as confidential, if submitted
previously issued final guidances notice of availability that appeared in as detailed in ‘‘Instructions.’’
located in the annual agenda website, the Federal Register of August 17, 2018. Instructions: All submissions received
feedback on any guidance is appreciated FDA requested comments on the draft must include the Docket No. FDA–
and will be considered. guidance for industry and FDA staff 2018–D–2310 for ‘‘Process to Request a
entitled ‘‘Process To Request a Review Review of FDA’s Decision Not to Issue
III. Website Location of Guidance Lists
of FDA’s Decision Not To Issue Certain Certain Export Certificates for Devices;
This notice announces the website Export Certificates for Devices.’’ The Draft Guidance for Industry and Food
location of the document that provides Agency is taking this action in response and Drug Administration Staff.’’
the A and B lists of guidance to a request for an extension to allow Received comments will be placed in
documents, which CDRH is intending to interested persons additional time to the docket and, except for those
publish during FY 2019. To access these submit comments. submitted as ‘‘Confidential
two lists, visit FDA’s website at https:// DATES: FDA is extending the comment Submissions,’’ publicly viewable at
www.fda.gov/MedicalDevices/ period on the document published https://www.regulations.gov or at the
DeviceRegulationandGuidance/ August 17, 2018 (83 FR 41078). Submit Dockets Management Staff between 9
GuidanceDocuments/ucm529396.htm. either electronic or written comments a.m. and 4 p.m., Monday through
We note that the topics on this and past on the draft guidance by November 15, Friday.
guidance priority lists may be removed 2018, to ensure that the Agency • Confidential Submissions—To
or modified based on current priorities, considers your comment on this draft submit a comment with confidential
as well as comments received regarding guidance before it begins work on the information that you do not wish to be
these lists. Furthermore, FDA and CDRH final version of the guidance. made publicly available, submit your
priorities are subject to change at any ADDRESSES: You may submit comments comments only as a written/paper
time (e.g., newly identified safety on any guidance at any time as follows: submission. You should submit two
issues). The Agency is not required to copies total. One copy will include the
publish every guidance on either list if Electronic Submissions information you claim to be confidential
the resources needed would be to the Submit electronic comments in the with a heading or cover note that states
detriment of meeting quantitative following way: ‘‘THIS DOCUMENT CONTAINS
review timelines and statutory • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
obligations. In addition, the Agency is https://www.regulations.gov. Follow the Agency will review this copy, including
not precluded from issuing guidance instructions for submitting comments. the claimed confidential information, in
documents that are not on either list. Comments submitted electronically, its consideration of comments. The
Stakeholder feedback on guidance including attachments, to https:// second copy, which will have the
priorities is important to ensure that the www.regulations.gov will be posted to claimed confidential information
CDRH guidance program meets the the docket unchanged. Because your redacted/blacked out, will be available
needs of stakeholders. The feedback comment will be made public, you are for public viewing and posted on
received on the FY 2018 list was mostly solely responsible for ensuring that your https://www.regulations.gov. Submit
in agreement, and CDRH continued to comment does not include any both copies to the Dockets Management
work toward issuing the guidances on confidential information that you or a Staff. If you do not wish your name and
this list. In FY 2018, CDRH issued third party may not wish to be posted, contact information to be made publicly
sixteen of twenty guidances on the FY such as medical information, your or available, you can provide this
2018 list (fourteen from the A-list, two anyone else’s Social Security number, or information on the cover sheet and not
daltland on DSKBBV9HB2PROD with NOTICES
from the B-list). confidential business information, such in the body of your comments and you
as a manufacturing process. Please note must identify this information as
Dated: September 28, 2018. that if you include your name, contact ‘‘confidential.’’ Any information marked
Leslie Kux, information, or other information that as ‘‘confidential’’ will not be disclosed
Associate Commissioner for Policy. identifies you in the body of your except in accordance with 21 CFR 10.20
[FR Doc. 2018–21596 Filed 10–3–18; 8:45 am] comments, that information will be and other applicable disclosure law. For
BILLING CODE 4164–01–P posted on https://www.regulations.gov. more information about FDA’s posting
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![50110 Federal Register / Vol. 83, No. 193 / Thursday, October 4, 2018 / Notices
of comments to public dockets, see 80 FDA’s Decision Not to Issue Certain (OMB) under the Paperwork Reduction
FR 56469, September 18, 2015, or access Export Certificates for Devices.’’ Act of 1995 (44 U.S.C. 3501–3520). The
the information at: https://www.gpo.gov/ The Agency has received a request for collections of information in sections
fdsys/pkg/FR-2015-09-18/pdf/2015- a 30-day extension of the comment 801(e) and 802 of the Federal Food,
23389.pdf. period. The request conveyed concern Drug and Cosmetic Act (21 U.S.C. 381(e)
Docket: For access to the docket to that the current 60-day comment period and 382) have been approved under
read background documents or the does not allow sufficient time to OMB control number 0910–0498; the
electronic and written/paper comments develop a meaningful or thoughtful collections of information in 21 CFR
received, go to https:// response. part 807, subparts A through E, have
www.regulations.gov and insert the FDA has considered the request and been approved under OMB control
docket number, found in brackets in the is extending the comment period for the number 0910–0625; the collections of
heading of this document, into the notice of availability for 30 days, until information in 21 CFR part 820 have
‘‘Search’’ box and follow the prompts November 15, 2018. The Agency been approved under OMB control
and/or go to the Dockets Management believes that a 30-day extension allows number 0910–0073; and the collections
Staff, 5630 Fishers Lane, Rm. 1061, adequate time for interested persons to of information in the guidance ‘‘Center
Rockville, MD 20852. submit comments without significantly for Devices and Radiological Health
You may submit comments on any delaying guidance on these important Appeals Processes’’ have been approved
guidance at any time (see 21 CFR issues. under OMB control number 0910–0738.
10.115(g)(5)). II. Significance of Guidance Dated: September 28, 2018.
An electronic copy of the guidance This draft guidance is being issued Leslie Kux,
document is available for download consistent with FDA’s good guidance Associate Commissioner for Policy.
from the internet. See the practices regulation (21 CFR 10.115). [FR Doc. 2018–21597 Filed 10–3–18; 8:45 am]
SUPPLEMENTARY INFORMATION section for The draft guidance, when finalized, will BILLING CODE 4164–01–P
information on electronic access to the represent the current thinking of FDA
guidance. Submit written requests for a on the process to request a review of
single hard copy of the draft guidance FDA’s decision not to issue certain DEPARTMENT OF HEALTH AND
document entitled ‘‘Process to Request a export certificates for devices. It does HUMAN SERVICES
Review of FDA’s Decision Not to Issue not establish any rights for any person
Certain Export Certificates for Devices; and is not binding on FDA or the public. Food and Drug Administration
Draft Guidance for Industry and Food You can use an alternative approach if [Docket No. FDA–2018–N–3636]
and Drug Administration Staff’’ to the it satisfies the requirements of the
Office of the Center Director, Guidance applicable statutes and regulations. This United States Food and Drug
and Policy Development, Center for guidance is not subject to Executive Administration and Health Canada
Devices and Radiological Health, Food Order 12866. Joint Public Consultation on the
and Drug Administration, 10903 New International Council for
Hampshire Ave., Bldg. 66, Rm. 5431, III. Electronic Access
Harmonisation of Technical
Silver Spring, MD 20993–0002, or the Persons interested in obtaining a copy Requirements for Pharmaceuticals for
Office of Communication, Outreach, and of the draft guidance may do so by Human Use; Public Meeting and
Development, Center for Biologics downloading an electronic copy from Webcast; Request for Comments
Evaluation and Research, Food and the internet. A search capability for all
Drug Administration, 10903 New Center for Devices and Radiological AGENCY: Food and Drug Administration,
Hampshire Ave., Bldg. 71, Rm. 3128, Health guidance documents is available HHS.
Silver Spring, MD 20993–0002. Send at https://www.fda.gov/MedicalDevices/ ACTION:Notice of public meeting and
one self-addressed adhesive label to DeviceRegulationandGuidance/ webcast; request for comments.
assist that office in processing your GuidanceDocuments/default.htm. This
request. guidance document is also available at SUMMARY: The Food and Drug
https://www.fda.gov/BiologicsBlood Administration (FDA or Agency) is
FOR FURTHER INFORMATION CONTACT: announcing a regional public meeting
Vaccines/GuidanceCompliance
Joann Belt, Center for Devices and entitled ‘‘U.S. Food and Drug
RegulatoryInformation/default.htm or
Radiological Health, Food and Drug Administration and Health Canada Joint
https://www.regulations.gov. Persons
Administration, 10903 New Hampshire Public Consultation on International
unable to download an electronic copy
Ave., Bldg. 66, Rm. 3658, Silver Spring, Council for Harmonisation of Technical
of ‘‘Process to Request a Review of
MD 20993–0002, joann.belt@ Requirements for Pharmaceuticals for
FDA’s Decision Not to Issue Certain
fda.hhs.gov, 301–796–6836; or Stephen Human Use (ICH).’’ The purpose of this
Export Certificates for Devices; Draft
Ripley, Center for Biologics Evaluation public meeting is to provide information
Guidance for Industry and Food and
and Research, Food and Drug and solicit public input on the current
Drug Administration Staff’’ may send an
Administration, 10903 New Hampshire activities of ICH as well as the
email request to CDRH-Guidance@
Ave, Bldg. 71, Rm. 7301, Silver Spring, upcoming ICH Assembly Meeting and
fda.hhs.gov to receive an electronic
MD 20993, 240–402–7911. the Expert Working Group Meetings in
copy of the document. Please use the
SUPPLEMENTARY INFORMATION: document number 17044 to identify the Charlotte, NC, scheduled for November
guidance you are requesting. 11 through 15, 2018. The topics to be
daltland on DSKBBV9HB2PROD with NOTICES
I. Background discussed are the topics for discussion
In the Federal Register of August 17, IV. Paperwork Reduction Act of 1995 at the forthcoming ICH Assembly
2018, FDA published a notice of This draft guidance refers to Meeting in Charlotte, NC.
availability with a 60-day comment previously approved collections of DATES: The public meeting will be held
period to request comments on the draft information. These collections of on October 17, 2018, from 9 a.m. to 12
guidance for industry and FDA staff information are subject to review by the p.m., Eastern Time. Submit either
entitled ‘‘Process to Request a Review of Office of Management and Budget electronic or written comments on this
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Document Created: 2018-10-04 02:03:06
Document Modified: 2018-10-04 02:03:06
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability; extension of comment period. | |
| Dates | FDA is extending the comment period on the document published August 17, 2018 (83 FR 41078). Submit either electronic or written comments on the draft guidance by November 15, 2018, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| 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, [email protected], 301-796-6836; 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 Citation | 83 FR 50109 |
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