83 FR 3739 - Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period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 18 (January 26, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 18 (January 26, 2018)
| Page Range | 3739-3740 | |
| FR Document | 2018-01349 |
[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)] [Notices] [Pages 3739-3740] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-01349] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-5570] Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period AGENCY: Food and Drug Administration, HHS.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 November 29, 2017. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled ``Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic 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 November 29, 2017 (82 FR 56607). Submit either electronic or written comments on the draft guidance by March 30, 2018, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-5570 for ``Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; 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 [[Page 3740]] 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 ``Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices'' 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: Marina Kondratovich, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4672, Silver Spring, MD 20993-0002, 301-796-6036; or 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 ``Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.'' 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 the 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. 2018-01349 Filed 1-25-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices 3739
This determination of the regulatory ACTION:Notice of availability; extension Management Staff (HFA–305), Food and
review period establishes the maximum of comment period. Drug Administration, 5630 Fishers
potential length of a patent extension. Lane, Rm. 1061, Rockville, MD 20852.
However, the USPTO applies several SUMMARY: The Food and Drug • For written/paper comments
statutory limitations in its calculations Administration (FDA or the Agency) is submitted to the Dockets Management
of the actual period for patent extension. extending the comment period for the Staff, FDA will post your comment, as
In its applications for patent extension, notice of availability that appeared in well as any attachments, except for
this applicant seeks 905 or 275 days of the Federal Register of November 29, information submitted, marked and
patent term extension. 2017. In the notice of availability, FDA identified, as confidential, if submitted
requested comments on draft guidance as detailed in ‘‘Instructions.’’
III. Petitions for industry and FDA staff entitled Instructions: All submissions received
Anyone with knowledge that any of ‘‘Select Updates for Recommendations must include the Docket No. FDA–
the dates as published are incorrect may for Clinical Laboratory Improvement 2017–D–5570 for ‘‘Select Updates for
submit either electronic or written Amendments of 1988 (CLIA) Waiver Recommendations for Clinical
comments and, under 21 CFR 60.24, ask Applications for Manufacturers of In Laboratory Improvement Amendments
for a redetermination (see DATES). Vitro Diagnostic Devices.’’ The Agency of 1988 (CLIA) Waiver Applications for
Furthermore, as specified in § 60.30 (21 is taking this action in response to a Manufacturers of In Vitro Diagnostic
CFR 60.30), any interested person may request for an extension to allow Devices; Draft Guidance for Industry
petition FDA for a determination interested persons additional time to and Food and Drug Administration
regarding whether the applicant for submit comments. Staff; Availability.’’ Received comments
extension acted with due diligence DATES: FDA is extending the comment will be placed in the docket and, except
during the regulatory review period. To period on the document published for those submitted as ‘‘Confidential
meet its burden, the petition must November 29, 2017 (82 FR 56607). Submissions,’’ publicly viewable at
comply with all the requirements of Submit either electronic or written https://www.regulations.gov or at the
§ 60.30, including but not limited to: comments on the draft guidance by Dockets Management Staff between 9
Must be timely (see DATES), must be March 30, 2018, to ensure that the a.m. and 4 p.m., Monday through
filed in accordance with § 10.20, must Agency considers your comment on this Friday.
draft guidance before it begins work on • Confidential Submissions—To
contain sufficient facts to merit an FDA
the final version of the guidance. submit a comment with confidential
investigation, and must certify that a
ADDRESSES: You may submit comments information that you do not wish to be
true and complete copy of the petition
on any guidance at any time as follows: made publicly available, submit your
has been served upon the patent
comments only as a written/paper
applicant. (See H. Rept. 857, part 1, 98th Electronic Submissions submission. You should submit two
Cong., 2d sess., pp. 41–42, 1984.) copies total. One copy will include the
Petitions should be in the format Submit electronic comments in the
following way: information you claim to be confidential
specified in 21 CFR 10.30.
• Federal eRulemaking Portal: with a heading or cover note that states
Submit petitions electronically to https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
https://www.regulations.gov at Docket instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
No. FDA–2013–S–0610. Submit written Comments submitted electronically, Agency will review this copy, including
petitions (two copies are required) to the including attachments, to https:// the claimed confidential information, in
Dockets Management Staff (HFA–305), www.regulations.gov will be posted to its consideration of comments. The
Food and Drug Administration, 5630 the docket unchanged. Because your second copy, which will have the
Fishers Lane, Rm. 1061, Rockville, MD comment will be made public, you are claimed confidential information
20852. solely responsible for ensuring that your redacted/blacked out, will be available
Dated: January 19, 2018. comment does not include any for public viewing and posted on
Leslie Kux, confidential information that you or a https://www.regulations.gov. Submit
Associate Commissioner for Policy. third party may not wish to be posted, both copies to the Dockets Management
[FR Doc. 2018–01368 Filed 1–25–18; 8:45 am] such as medical information, your or Staff. If you do not wish your name and
anyone else’s Social Security number, or contact information to be made publicly
BILLING CODE 4164–01–P
confidential business information, such available, you can provide this
as a manufacturing process. Please note information on the cover sheet and not
DEPARTMENT OF HEALTH AND that if you include your name, contact in the body of your comments and you
HUMAN SERVICES information, or other information that must identify this information as
identifies you in the body of your ‘‘confidential.’’ Any information marked
Food and Drug Administration comments, that information will be as ‘‘confidential’’ will not be disclosed
posted on https://www.regulations.gov. except in accordance with 21 CFR 10.20
[Docket No. FDA–2017–D–5570] • If you want to submit a comment and other applicable disclosure law. For
with confidential information that you more information about FDA’s posting
Select Updates for Recommendations do not wish to be made available to the of comments to public dockets, see 80
for Clinical Laboratory Improvement public, submit the comment as a FR 56469, September 18, 2015, or access
Amendments of 1988 Waiver written/paper submission and in the the information at: https://www.gpo.gov/
Applications for Manufacturers of In manner detailed (see ‘‘Written/Paper fdsys/pkg/FR-2015-09-18/pdf/2015-
daltland on DSKBBV9HB2PROD with NOTICES
Vitro Diagnostic Devices; Draft Submissions’’ and ‘‘Instructions’’). 23389.pdf.
Guidance for Industry and Food and Docket: For access to the docket to
Written/Paper Submissions read background documents or the
Drug Administration Staff; Availability;
Extension of Comment Period Submit written/paper submissions as electronic and written/paper comments
follows: received, go to https://
AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
HHS. written/paper submissions): Dockets docket number, found in brackets in the
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![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)
VerDate Sep<11>2014 20:14 Jan 25, 2018 Jkt 244001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\26JAN1.SGM 26JAN1](https://thefederalregister.org/doc/83_FR_3757/page/2.svg)
Document Created: 2018-10-26 10:05:01
Document Modified: 2018-10-26 10:05:01
| 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 56607). 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 | Marina Kondratovich, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4672, Silver Spring, MD 20993-0002, 301-796-6036; or 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 3739 |
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