[Federal Register Volume 89, Number 202 (Friday, October 18, 2024)]
[Notices]
[Pages 83889-83890]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24096]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-3805]


The Accreditation Scheme for Conformity Assessment Program: Draft 
Guidances for Industry, Accreditation Bodies, Testing Laboratories, and 
FDA Staff; Availability; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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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 September 23, 2024. In the notice 
of availability, FDA requested comments on three draft guidance 
documents for industry and FDA staff entitled ``The Accreditation 
Scheme for Conformity Assessment (ASCA) Program; Guidance for Industry, 
Accreditation Bodies, Testing Laboratories, and FDA Staff''; ``Basic 
Safety and Essential Performance of Medical Electrical Equipment, 
Medical Electrical Systems, and Laboratory Medical Equipment--Standards 
Specific Information for the ASCA Program; Guidance for Industry, 
Accreditation Bodies, Testing Laboratories, and FDA Staff''; and 
``Biocompatibility Testing of Medical Devices--Standards Specific 
Information for the ASCA Program; Guidance for Industry, Accreditation 
Bodies, Testing Laboratories, and FDA Staff.'' 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 
September 23, 2024 (89 FR 77526). Either electronic or written comments 
must be submitted by December 23, 2024, 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considers your comment on this draft guidance before it begins work on 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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-2019-D-3805 for ``The Accreditation Scheme for Conformity 
Assessment (ASCA) Program; Guidance for Industry, Accreditation Bodies, 
Testing Laboratories, and FDA Staff''; ``Basic Safety and Essential 
Performance of Medical Electrical Equipment, Medical Electrical 
Systems, and Laboratory Medical Equipment--Standards Specific 
Information for the ASCA Program; Guidance for Industry, Accreditation 
Bodies, Testing Laboratories, and FDA Staff''; and ``Biocompatibility 
Testing of Medical Devices--Standards Specific Information for the ASCA 
Program; Guidance for Industry, Accreditation Bodies, Testing 
Laboratories, and FDA 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, 240-
402-7500.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your

[[Page 83890]]

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.govinfo.gov/content/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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Eric Franca, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5500, Silver Spring, MD 20993-0002, 301-796-4505, 
<a href="/cdn-cgi/l/email-protection#d19082929091b7b5b0ffb9b9a2ffb6bea7"><span class="__cf_email__" data-cfemail="f3b2a0b0b2b3959792dd9b9b80dd949c85">[email protected]</span></a>; or James Myers, 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: In the Federal Register of September 23, 
2024, FDA published a notice of availability with a 60-day comment 
period to request comments on draft guidances for industry and FDA 
staff entitled ``The Accreditation Scheme for Conformity Assessment 
(ASCA) Program; Guidance for Industry, Accreditation Bodies, Testing 
Laboratories, and FDA Staff''; ``Basic Safety and Essential Performance 
of Medical Electrical Equipment, Medical Electrical Systems, and 
Laboratory Medical Equipment--Standards Specific Information for the 
ASCA Program; Guidance for Industry, Accreditation Bodies, Testing 
Laboratories, and FDA Staff''; and ``Biocompatibility Testing of 
Medical Devices--Standards Specific Information for the ASCA Program; 
Guidance for Industry, Accreditation Bodies, Testing Laboratories, and 
FDA Staff.''
    The Agency has received a request for an 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 December 23, 2024. 
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.

    Dated: October 10, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024-24096 Filed 10-17-24; 8:45 am]
BILLING CODE 4164-01-P


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