89 FR 202 pgs. 83889-83890 - The Accreditation Scheme for Conformity Assessment Program: Draft Guidances for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff; Availability; Extension of Comment Period
Type: NOTICEVolume: 89Number: 202Pages: 83889 - 83890
Pages: 83889, 83890Docket number: [Docket No. FDA-2019-D-3805]
FR document: [FR Doc. 2024-24096 Filed 10-17-24; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
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 In the notice of availability, FDA requested comments on three draft guidance documents for industry and FDA staff entitled "The Accreditation Scheme for Conformity Assessment (ASCA) Program; Guidance for Industry, Accreditation Bodies,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or written comments must be submitted by December 23, 2024, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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:
• 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-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.
[top] • Confidential Submissions-To submit a comment with confidential information that you do not wish to be made publicly available, submit your
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, ASCA@fda.hhs.gov; 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]
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