83 FR 3740 - Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period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 18 (January 26, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 18 (January 26, 2018)
| Page Range | 3740-3741 | |
| FR Document | 2018-01350 |
[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)] [Notices] [Pages 3740-3741] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-01350] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-5625] Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period AGENCY: Food and Drug Administration, HHS.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 November 29, 2017. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled ``Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application Studies.'' 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 November 29, 2017 (82 FR 56610). Submit either electronic or written comments on the draft guidance by March 30, 2018, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-2017-D-5625 for ``Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) [[Page 3741]] Waiver by Application Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability.'' 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 ``Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability'' 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: Peter Tobin, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 5657, Silver Spring, MD 20993-0002, 240-402-6169. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of November 29, 2017, FDA published a notice of availability with a 60-day comment period to request comments on draft guidance for industry and FDA staff entitled ``Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application Studies.'' 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 guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles to the activities pertaining to products meeting the statutory definition of a device regulated under the Federal Food, Drug, and Cosmetic Act. 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 draft guidance is not subject to Executive Order 12866. The Agency has received a request for a 60-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 60 days, until March 30, 2018. The Agency believes that a 60-day extension allows adequate time for interested persons to submit comments without significantly delaying guidance on these important issues. II. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: January 19, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-01350 Filed 1-25-18; 8:45 am] BILLING CODE 4164-01-P
![3740 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices
heading of this document, into the Act. It does not establish any rights for taking this action in response to a
‘‘Search’’ box and follow the prompts any person and is not binding on FDA request for an extension to allow
and/or go to the Dockets Management or the public. You can use an alternative interested persons additional time to
Staff, 5630 Fishers Lane, Rm. 1061, approach if it satisfies the requirements submit comments.
Rockville, MD 20852. of the applicable statutes and DATES: FDA is extending the comment
You may submit comments on any regulations. This draft guidance is not period on the document published
guidance at any time (see 21 CFR subject to Executive Order 12866. November 29, 2017 (82 FR 56610).
10.115(g)(5)). The Agency has received a request for Submit either electronic or written
An electronic copy of the guidance a 60-day extension of the comment comments on the draft guidance by
document is available for download period. The request conveyed concern March 30, 2018, to ensure that the
from the internet. See the that the current 60-day comment period Agency considers your comment on this
SUPPLEMENTARY INFORMATION section for does not allow sufficient time to draft guidance before it begins work on
information on electronic access to the develop a meaningful or thoughtful the final version of the guidance.
guidance. Submit written requests for a response.
FDA has considered the request and ADDRESSES: You may submit comments
single hard copy of the draft guidance on any guidance at any time as follows:
document entitled ‘‘Select Updates for is extending the comment period for the
Recommendations for Clinical notice of availability for 60 days, until Electronic Submissions
Laboratory Improvement Amendments March 30, 2018. The Agency believes
that a 60-day extension allows adequate Submit electronic comments in the
of 1988 Waiver Applications for following way:
Manufacturers of In Vitro Diagnostic time for interested persons to submit
comments without significantly • Federal eRulemaking Portal:
Devices’’ to the Office of the Center https://www.regulations.gov. Follow the
Director, Guidance and Policy delaying guidance on these important
issues. instructions for submitting comments.
Development, Center for Devices and Comments submitted electronically,
Radiological Health, Food and Drug II. Electronic Access including attachments, to https://
Administration, 10903 New Hampshire www.regulations.gov will be posted to
Persons with access to the internet
Ave., Bldg. 66, Rm. 5431, Silver Spring, the docket unchanged. Because your
may obtain the draft guidance at either
MD 20993–0002. Send one self- comment will be made public, you are
https://www.fda.gov/Drugs/Guidance
addressed adhesive label to assist that solely responsible for ensuring that your
ComplianceRegulatoryInformation/
office in processing your request. comment does not include any
Guidances/default.htm or https://
FOR FURTHER INFORMATION CONTACT: www.regulations.gov. confidential information that you or a
Marina Kondratovich, Center for third party may not wish to be posted,
Devices and Radiological Health, Food Dated: January 19, 2018.
such as medical information, your or
and Drug Administration, 10903 New Leslie Kux,
anyone else’s Social Security number, or
Hampshire Ave., Bldg. 66, Rm. 4672, Associate Commissioner for Policy. confidential business information, such
Silver Spring, MD 20993–0002, 301– [FR Doc. 2018–01349 Filed 1–25–18; 8:45 am] as a manufacturing process. Please note
796–6036; or Peter Tobin, Center for BILLING CODE 4164–01–P that if you include your name, contact
Devices and Radiological Health, Food information, or other information that
and Drug Administration, 10903 New identifies you in the body of your
Hampshire Ave., Bldg. 66, Rm. 5657, DEPARTMENT OF HEALTH AND comments, that information will be
Silver Spring, MD 20993–0002, 240– HUMAN SERVICES posted on https://www.regulations.gov.
402–6169.
Food and Drug Administration • If you want to submit a comment
SUPPLEMENTARY INFORMATION: with confidential information that you
[Docket No. FDA–2017–D–5625] do not wish to be made available to the
I. Background
public, submit the comment as a
In the Federal Register of November Recommendations for Dual 510(k) and written/paper submission and in the
29, 2017, FDA published a notice of Clinical Laboratory Improvement manner detailed (see ‘‘Written/Paper
availability with a 60-day comment Amendments Waiver by Application Submissions’’ and ‘‘Instructions’’).
period to request comments on draft Studies; Draft Guidance for Industry
guidance for industry and FDA staff and Food and Drug Administration Written/Paper Submissions
entitled ‘‘Select Updates for Staff; Availability; Extension of Submit written/paper submissions as
Recommendations for Clinical Comment Period follows:
Laboratory Improvement Amendments AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for
of 1988 (CLIA) Waiver Applications for HHS. written/paper submissions): Dockets
Manufacturers of In Vitro Diagnostic ACTION:Notice of availability; extension Management Staff (HFA–305), Food and
Devices.’’ of comment period. Drug Administration, 5630 Fishers
This draft guidance is being issued Lane, Rm. 1061, Rockville, MD 20852.
consistent with FDA’s good guidance SUMMARY: The Food and Drug • For written/paper comments
practices regulation (21 CFR 10.115). Administration (FDA or the Agency) is submitted to the Dockets Management
The draft guidance, when finalized, will extending the comment period for the Staff, FDA will post your comment, as
represent the current thinking of the notice of availability that appeared in well as any attachments, except for
FDA on the guiding principles and the Federal Register of November 29, information submitted, marked and
daltland on DSKBBV9HB2PROD with NOTICES
recommended approach for FDA staff 2017. In the notice of availability, FDA identified, as confidential, if submitted
and industry to facilitate consistent requested comments on draft guidance as detailed in ‘‘Instructions.’’
application of least burdensome for industry and FDA staff entitled Instructions: All submissions received
principles to the activities pertaining to ‘‘Recommendations for Dual 510(k) and must include the Docket No. FDA–
products meeting the statutory Clinical Laboratory Improvement 2017–D–5625 for ‘‘Recommendations
definition of a device regulated under Amendments (CLIA) Waiver by for Dual 510(k) and Clinical Laboratory
the Federal Food, Drug, and Cosmetic Application Studies.’’ The Agency is Improvement Amendments (CLIA)
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![Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices 3741
Waiver by Application Studies; Draft for Dual 510(k) and Clinical Laboratory II. Electronic Access
Guidance for Industry and Food and Improvement Amendments (CLIA) Persons with access to the internet
Drug Administration Staff; Waiver by Application Studies; Draft may obtain the draft guidance at either
Availability.’’ Received comments will Guidance for Industry and Food and https://www.fda.gov/Drugs/Guidance
be placed in the docket and, except for Drug Administration Staff; Availability’’ ComplianceRegulatoryInformation/
those submitted as ‘‘Confidential to the Office of the Center Director, Guidances/default.htm or https://
Submissions,’’ publicly viewable at Guidance and Policy Development, www.regulations.gov.
https://www.regulations.gov or at the Center for Devices and Radiological
Dockets Management Staff between 9 Health, Food and Drug Administration, Dated: January 19, 2018.
a.m. and 4 p.m., Monday through 10903 New Hampshire Ave., Bldg. 66, Leslie Kux,
Friday. Rm. 5431, Silver Spring, MD 20993– Associate Commissioner for Policy.
• Confidential Submissions—To 0002. Send one self-addressed adhesive [FR Doc. 2018–01350 Filed 1–25–18; 8:45 am]
submit a comment with confidential label to assist that office in processing BILLING CODE 4164–01–P
information that you do not wish to be your request.
made publicly available, submit your FOR FURTHER INFORMATION CONTACT:
comments only as a written/paper Peter Tobin, Center for Devices and DEPARTMENT OF HEALTH AND
submission. You should submit two Radiological Health, Food and Drug HUMAN SERVICES
copies total. One copy will include the Administration, 10903 New Hampshire
information you claim to be confidential Ave. Bldg. 66, Rm. 5657, Silver Spring, Food and Drug Administration
with a heading or cover note that states MD 20993–0002, 240–402–6169.
‘‘THIS DOCUMENT CONTAINS [Docket No. FDA–2018–N–0181]
CONFIDENTIAL INFORMATION.’’ The SUPPLEMENTARY INFORMATION:
Agency will review this copy, including International Drug Scheduling;
I. Background Convention on Psychotropic
the claimed confidential information, in
its consideration of comments. The In the Federal Register of November Substances; Single Convention on
second copy, which will have the 29, 2017, FDA published a notice of Narcotic Drugs; World Health
claimed confidential information availability with a 60-day comment Organization; Scheduling
redacted/blacked out, will be available period to request comments on draft Recommendations; Carfentanil;
for public viewing and posted on guidance for industry and FDA staff 4-fluoroamphetamine (4–FA) and Ten
https://www.regulations.gov. Submit entitled ‘‘Recommendations for Dual Other Substances; Request for
both copies to the Dockets Management 510(k) and Clinical Laboratory Comments
Staff. If you do not wish your name and Improvement Amendments (CLIA)
Waiver by Application Studies.’’ AGENCY: Food and Drug Administration,
contact information to be made publicly HHS.
available, you can provide this This draft guidance is being issued
consistent with FDA’s good guidance ACTION: Notice; request for comments.
information on the cover sheet and not
in the body of your comments and you practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will SUMMARY: The Food and Drug
must identify this information as Administration (FDA) is providing
‘‘confidential.’’ Any information marked represent the current thinking of FDA
on the guiding principles and interested persons with the opportunity
as ‘‘confidential’’ will not be disclosed to submit written comments concerning
except in accordance with 21 CFR 10.20 recommended approach for FDA staff
and industry to facilitate consistent recommendations by the World Health
and other applicable disclosure law. For Organization (WHO) to impose
more information about FDA’s posting application of least burdensome
principles to the activities pertaining to international manufacturing and
of comments to public dockets, see 80 distributing restrictions, under
FR 56469, September 18, 2015, or access products meeting the statutory
definition of a device regulated under international treaties, on certain drug
the information at: https://www.gpo.gov/ substances. The comments received in
fdsys/pkg/FR-2015-09-18/pdf/2015- the Federal Food, Drug, and Cosmetic
Act. It does not establish any rights for response to this notice will be
23389.pdf. considered in preparing the United
Docket: For access to the docket to any person and is not binding on FDA
or the public. You can use an alternative States’ position on these proposals for a
read background documents or the meeting of the United Nations
electronic and written/paper comments approach if it satisfies the requirements
of the applicable statutes and Commission on Narcotic Drugs (CND) in
received, go to https:// Vienna, Austria, in March 2018. This
www.regulations.gov and insert the regulations. This draft guidance is not
subject to Executive Order 12866. notice is issued under the Controlled
docket number, found in brackets in the Substances Act (CSA).
heading of this document, into the The Agency has received a request for
Search box and follow the prompts and/ a 60-day extension of the comment DATES: Submit either electronic or
or go to the Dockets Management Staff, period. The request conveyed concern written comments by February 26, 2018.
5630 Fishers Lane, Rm. 1061, Rockville, that the current 60-day comment period ADDRESSES: You may submit comments
MD 20852. does not allow sufficient time to as follows. Please note that late,
You may submit comments on any develop a meaningful or thoughtful untimely filed comments will not be
guidance at any time (see 21 CFR response. considered. Electronic comments must
10.115(g)(5)). FDA has considered the request and be submitted on or before February 26,
An electronic copy of the guidance is extending the comment period for the 2018. The https://www.regulations.gov
daltland on DSKBBV9HB2PROD with NOTICES
document is available for download notice of availability for 60 days, until electronic filing system will accept
from the internet. See the March 30, 2018. The Agency believes comments until midnight Eastern Time
SUPPLEMENTARY INFORMATION section for that a 60-day extension allows adequate at the end of February 26, 2018.
information on electronic access to the time for interested persons to submit Comments received by mail/hand
guidance. Submit written requests for a comments without significantly delivery/courier (for written/paper
single hard copy of the draft guidance delaying guidance on these important submissions) will be considered timely
document entitled ‘‘Recommendations issues. if they are postmarked or the delivery
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Document Created: 2018-10-26 10:06:05
Document Modified: 2018-10-26 10:06:05
| 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 November 29, 2017 (82 FR 56610). Submit either electronic or written comments on the draft guidance by March 30, 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 | Peter Tobin, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 5657, Silver Spring, MD 20993-0002, 240-402-6169. | |
| FR Citation | 83 FR 3740 |
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