The Accreditation Scheme for Conformity Assessment Program: Draft Guidances for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff; Availability; Extension of Comment Period, 83889-83890 [2024-24096]
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Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices
recommendations on how to provide the
relevant information to FDA.
This guidance finalizes the draft
guidance of the same title issued on
October 6, 2022 (87 FR 60686). FDA
considered comments received on the
draft guidance as the guidance was
finalized, and in response a footnote
was added to clarify the potential
impact of unsolicited amendments
submitted after the prior assessment is
granted.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Review of Drug
Master Files in Advance of Certain
ANDA Submissions Under GDUFA.’’ 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.
II. Paperwork Reduction Act of 1995
While this final guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in 21 CFR 314 have been
approved under OMB control number
0910–0001.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: October 9, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024–24104 Filed 10–17–24; 8:45 am]
khammond on DSKJM1Z7X2PROD with NOTICES
BILLING CODE 4164–01–P
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.
Notice of availability; extension
of comment period.
ACTION:
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:
SUMMARY:
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
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16:48 Oct 17, 2024
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83889
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.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
E:\FR\FM\18OCN1.SGM
18OCN1
khammond on DSKJM1Z7X2PROD with NOTICES
83890
Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices
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-201509-18/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,
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
VerDate Sep<11>2014
16:48 Oct 17, 2024
Jkt 265001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–E–0128]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; Wavewriter Alpha Spinal
Cord Stimulator System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for WAVEWRITER ALPHA SPINAL
CORD STIMULATOR SYSTEM and is
publishing this notice of that
determination as required by law. FDA
has made the determination because of
the submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that medical
device.
SUMMARY:
Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by December 17, 2024.
DATES:
PO 00000
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Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
April 16, 2025. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
December 17, 2024]. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
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.’’
E:\FR\FM\18OCN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
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,
[email protected]; 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
