Notice2023-13860
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation Scheme for Conformity Assessment Program
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Published
June 29, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 88 Issue 124 (Thursday, June 29, 2023)</title>
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[Federal Register Volume 88, Number 124 (Thursday, June 29, 2023)]
[Notices]
[Pages 42076-42079]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-13860]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3657]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Accreditation Scheme
for Conformity Assessment Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by July 31, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0889. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#712123302205101717311715105f1919025f161e07"><span class="__cf_email__" data-cfemail="96c6c4d7c5e2f7f0f0d6f0f2f7b8fefee5b8f1f9e0">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Accreditation Scheme for Conformity Assessment Program
OMB Control Number 0910-0889--Revision
Section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 360d) provides for the establishment of performance
standards, authorizing the Accreditation Scheme for Conformity
Assessment Program (ASCA Program) under section 514(d). On September
25, 2020 (85 FR 60471), we announced the
[[Page 42077]]
implementation of a pilot program under which testing laboratories may
be accredited by ASCA-recognized accreditation bodies meeting criteria
specified by FDA to assess the conformance of a device to certain FDA-
recognized standards. These testing laboratories then receive ASCA
Accreditation from FDA. Determinations by ASCA-accredited testing
laboratories that a device conforms with an eligible standard included
as part of the program are accepted by FDA for the purposes of
demonstrating conformity unless FDA finds that a particular such
determination shall not be so accepted.\1\ The statute provides that
FDA may review determinations by accredited testing laboratories,
including by conducting periodic audits of such determinations or
processes of accreditation bodies or testing laboratories.\2\
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\1\ See section 514(d)(1)(B) of the FD&C Act.
\2\ See section 514(d)(2)(A) of the FD&C Act.
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Following such a review, or if FDA becomes aware of information
materially bearing on safety or effectiveness of a device tested by an
ASCA-accredited testing laboratory, FDA may take additional measures as
determined appropriate, including suspension or withdrawal of ASCA
Accreditation of a testing laboratory, withdrawal of ASCA Recognition
of an accreditation body, or a request for additional information
regarding a specific device.\3\ The establishment of the goals, scope,
procedures, and a suitable framework for the voluntary ASCA Program
supports the Agency's continued efforts to use its scientific resources
effectively and efficiently to protect and promote public health. FDA
believes the voluntary ASCA Program may further encourage international
harmonization of medical device regulation because it incorporates
elements, where appropriate, from a well-established set of
international conformity assessment practices and standards (e.g., ISO/
IEC 17000 series). The voluntary ASCA Program does not supplant or
alter any other existing statutory or regulatory requirements governing
the decision-making process for premarket submissions.
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\3\ See section 514(d)(2)(A)-(B) of the FD&C Act.
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We are revising the information collection to reflect recent
legislative changes. In accordance with amendments made to section 514
by the FDA Reauthorization Act of 2022 (FDARA),\4\ and as part of the
enactment of the Medical Device User Fee Amendments of 2022 (MDUFA
V),\5\ the ``pilot'' language and sunset clause was removed from the
section, allowing FDA to conclude the pilot and continue to operate the
program consistent with the amended section 514(d) of the FD&C Act. In
accordance with these updates and as included in the Center for Devices
and Radiological Health Proposed Guidances for Fiscal Year 2023,\6\ we
intend to update the applicable guidance documents.
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\4\ See Public Law 117-180, section 2005.
\5\ See also MDUFA V Commitment Letter: <a href="https://www.fda.gov/media/158308/download">https://www.fda.gov/media/158308/download</a>.
\6\ See CDRH Proposed Guidances for Fiscal Year 2023, B-list:
<a href="https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidances-fiscal-year-2023-fy2023#b">https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidances-fiscal-year-2023-fy2023#b</a>.
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Finally, to assist testing laboratories and accreditation bodies in
submitting information to FDA, we are developing webforms for applying
for ASCA Accreditation and ASCA Recognition, respectively.
Under the ASCA Program's conformity assessment scheme, ASCA-
recognized accreditation bodies accredit testing laboratories using
ISO/IEC 17025:2017: ``General requirements for the competence of
testing and calibration laboratories'' and the ASCA program
specifications associated with each eligible standard and test method
included in the ASCA Program. ASCA-accredited testing laboratories may
conduct testing to determine conformance of a device with at least one
of the standards eligible for inclusion in the ASCA Program. When an
ASCA-accredited testing laboratory conducts such testing, it provides a
complete test report and an ASCA Summary Test Report to the device
manufacturer. A device manufacturer who utilizes an ASCA-accredited
testing laboratory to perform testing in accordance with the provisions
of the ASCA Program can then include a declaration of conformity with
supplemental documentation (including an ASCA Summary Test Report) as
part of a premarket submission to FDA. Testing performed by an ASCA-
accredited testing laboratory can be used to support a premarket
submission for any device if the testing was conducted using a standard
included in the ASCA Program and in accordance with the ASCA program
specifications for that standard.
The ASCA Program includes participation from accreditation bodies,
testing laboratories, device manufacturers, and FDA staff. Each of
these entities plays a critical role in the ASCA Program to ensure that
patients and healthcare providers have timely and continued access to
safe, effective, and high-quality medical devices.
To participate in the ASCA Program, accreditation bodies and
testing laboratories apply to FDA to demonstrate that they have the
qualifications for their respective roles within the program. An
application includes agreement to terms of participation. For example,
a participating accreditation body or testing laboratory agrees to
attend training, regularly communicate with FDA, and support periodic
FDA audits. FDA will identify the scope of ASCA Recognition (for
accreditation bodies) and ASCA Accreditation (for testing laboratories)
for specific standards and test methods to which each participant may
accredit or test as part of the ASCA Program.
During the ASCA Program, FDA generally will accept test results
from ASCA-accredited testing laboratories to support conformity of a
medical device to a particular standard and does not intend to review
complete test reports from ASCA-accredited testing laboratories in
support of a declaration of conformity submitted with a premarket
submission except in certain circumstances.
Note that ASCA Accreditation is separate from any accreditation
that an accreditation body may provide to a testing laboratory for
purposes other than the ASCA Program.
The ASCA Program does not address specific content for a particular
premarket submission. Information collections associated with premarket
submissions have been previously approved.
We plan to issue draft guidance updates to the three published ASCA
Pilot guidance documents \7\ to improve and streamline the ASCA
Program. The guidance updates are being issued to discuss the lessons
learned during ASCA's pilot phase and to help
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facilitate the transition from a pilot to a permanent program. As a
result of these guidance updates, there is minimal adjustment to the
burden estimate.
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\7\ The Accreditation Scheme for Conformity Assessment (ASCA)
Pilot Program (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/accreditation-scheme-conformity-assessment-asca-pilot-program">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/accreditation-scheme-conformity-assessment-asca-pilot-program</a>). Basic Safety and Essential Performance of
Medical Electrical Equipment, Medical Electrical Systems, and
Laboratory Medical Equipment--Standards Specific Information for the
Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
(<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/basic-safety-and-essential-performance-medical-electrical-equipment-medical-electrical-systems-and">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/basic-safety-and-essential-performance-medical-electrical-equipment-medical-electrical-systems-and</a>). Biocompatibility Testing
of Medical Devices--Standards Specific Information for the
Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
(<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/biocompatibility-testing-medical-devices-standards-specific-information-accreditation-scheme">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/biocompatibility-testing-medical-devices-standards-specific-information-accreditation-scheme</a>).
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Respondents are accreditation bodies (ABs) and testing laboratories
(TLs). In tables 1 through 3, these abbreviations are used.
In the Federal Register of January 19, 2023 (88 FR 3419), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden per Total hours
respondents respondent responses response \2\
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Application by AB for ASCA 8 1 8 6................. 48
Recognition.
Request by AB to continue 2 1 2 6................. 12
ASCA Recognition.
Request by AB for ASCA 1 1 1 6................. 6
Recognition (subsequent to
withdrawal).
Request by AB to expand 1 1 1 6................. 6
scope of ASCA Recognition.
AB annual status report..... 8 1 8 3................. 24
AB notification of change... 8 1 8 1................. 8
Application by TL for ASCA 150 1 150 4................. 600
Accreditation.
Request by TL to continue 75 1 75 4................. 300
ASCA Accreditation.
Request by TL for ASCA 5 1 5 4................. 20
Accreditation (subsequent
to withdrawal or
suspension).
Request by TL to expand 75 1 75 4................. 300
scope of ASCA Accreditation.
TL annual status report..... 150 1 150 1.5............... 225
TL notification of change... 5 1 5 1................. 5
Request for withdrawal or 6 1 6 0.08 (5 minutes).. 1
suspension of ASCA
Accreditation (TLs) or
request for withdrawal of
ASCA Recognition (ABs).
Feedback questionnaire (ABs 158 1 158 0.5 (30 minutes).. 79
and TLs).
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Total................... .............. .............. .............. .................. 1,634
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\1\ Totals have been rounded to the nearest hour.
\2\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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AB setup documentation standard 3 1 3 25 75
operating procedures (SOPs) &
training (one-time burden).....
TL setup documentation SOPs & 20 1 20 25 500
training (one-time burden).....
AB record maintenance........... 8 1 8 1 8
TL record maintenance........... 150 1 150 1 150
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Total....................... .............. .............. .............. .............. 733
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
Number of disclosures Total annual Average burden per
Activity respondents per disclosures disclosure Total hours
respondent
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Request for Accreditation 150 1 150 0.5 (30 minutes).. 75
(TLs requesting
accreditation from ABs).
Review/Acknowledgement of 8 22 176 40................ 7,040
accreditation request (ABs).
Test Reports (TLs).......... 880 1 880 1................. 880
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Total................... .............. .............. .............. .................. 7,995
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Our estimate of eight ABs is based on the number of International
Laboratory Accreditation Cooperation signatories in the U.S. economy.
We estimate that approximately 150 testing labs will seek ASCA
Accreditation. Our estimate of Test Reports is based on the number of
premarket submissions we expect per year with testing from an ASCA-
accredited testing laboratory.
Our estimates for the number of respondents and average burden per
[[Page 42079]]
response, recordkeeping, and disclosure are based on our experience
with the pilot program.
Our estimated burden for the information collection reflects an
overall decrease of 3,129 hours and an increase of 94 responses/
records. We attribute this adjustment to a decrease in the one-time
burden for accreditation bodies and testing laboratories training and
SOPs because much of this activity was completed during the pilot. In
addition, there is an increase in the annual responses/records because
there is an increase in renewal requests (by accreditation bodies to
continue ASCA Recognition and by testing laboratories to continue ASCA
Accreditation) since the pilot program was initiated.
Dated: June 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13860 Filed 6-28-23; 8:45 am]
BILLING CODE 4164-01-P
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