Agency Information Collection Activities; Proposed Collection; Comment Request; Accreditation Scheme for Conformity Assessment Program

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Published

January 19, 2023

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with the Accreditation Scheme for Conformity Assessment (ASCA) Program.

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<title>Federal Register, Volume 88 Issue 12 (Thursday, January 19, 2023)</title>
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[Federal Register Volume 88, Number 12 (Thursday, January 19, 2023)]
[Notices]
[Pages 3419-3422]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-00973]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3657]

Agency Information Collection Activities; Proposed Collection;
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, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
associated with the Accreditation Scheme for Conformity Assessment
(ASCA) Program.

DATES: Either electronic or written comments on the collection of
information must be submitted by March 20, 2023.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 20, 2023. 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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-N-3657 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Accreditation Scheme for
Conformity Assessment Program.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#712123302205101717311715105f1919025f161e07"><span class="__cf_email__" data-cfemail="9ececcdfcdeafff8f8def8faffb0f6f6edb0f9f1e8">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites

[[Page 3420]]

comments on these topics: (1) whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.

Accreditation Scheme for Conformity Assessment Program

OMB Control Number 0910-0889--Extension

The FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-52)
amended section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360d(d)) by adding a new subsection (d) entitled
``Accreditation Scheme for Conformity Assessment.''
Section 514(d) of the FD&C Act required FDA to establish a pilot
program under which testing laboratories may be accredited by
accreditation bodies meeting criteria specified by FDA to assess the
conformance of a device within certain FDA-recognized standards.
Determinations by accredited testing laboratories that a device
conforms with an eligible standard included as part of the ASCA Program
shall be accepted by FDA for the purposes of demonstrating such
conformity unless FDA finds that a particular such determination shall
not be so accepted.
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.
Following such a review, or if FDA becomes aware of information
materially bearing on safety or effectiveness of a device assessed by
an accredited testing laboratory, FDA may take additional measures as
determined appropriate, including suspension or withdrawal of
accreditation of a testing laboratory or a request for additional
information regarding a specific device.
FDA issued the final guidance ``The Accreditation Scheme for
Conformity Assessment (ASCA) Pilot Program'' (<a href="https://www.fda.gov/media/130901/download">https://www.fda.gov/media/130901/download</a>) to discuss the goals and implementation of the
voluntary ASCA Pilot Program (hereafter referred to as the ASCA Program
in accordance with amendments made to section 514 of the FD&C Act by
FDARA, and as part of the enactment of the Medical Device User Fee
Amendments of 2017 (MDUFA IV)).
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.
Under the ASCA Program's conformity assessment scheme, recognized
accreditation bodies accredit testing laboratories using ASCA program
specifications associated with each eligible standard and ISO/IEC
17025:2017: General requirements for the competence of testing and
calibration laboratories. 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 may
provide a complete 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 a 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 eligible for inclusion 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 recognizes qualified applicants as participants. In its
recognition, FDA will identify the scope of recognition of specific
standards and test methods to which each participant may accredit or
test as part of the ASCA Program.
After recognizing a testing laboratory as a participant in the ASCA
Program, FDA will generally grant the testing laboratory ASCA
Accreditation. During the ASCA Program, FDA generally will accept
determinations from ASCA-accredited testing laboratories that a medical
device is in conformity with the specified testing 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. FDA's decision to recognize the
accreditation for purposes of the ASCA Program is separate and distinct
from any independent decision by the accreditation body with respect to
a testing laboratory for purposes outside of 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.
FDA plans to issue draft guidance updates to the three published
ASCA Pilot guidance documents \1\ to improve

[[Page 3421]]

and streamline the ASCA Program. The guidance updates are being issued
to discuss the lessons learned during ASCA's pilot phase and to also
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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\1\ The Accreditation Scheme for Conformity Assessment (ASCA)
Pilot Program [verbar] FDA (<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 [verbar] FDA (<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 [verbar] FDA (<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.
FDA estimates the burden of this collection of information 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 response Total hours
respondents respondent responses \2\
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Application by AB for ASCA Recognition........ 8 1 8 6....................................... 48
Request by AB to continue ASCA Recognition.... 2 1 2 6....................................... 12
Request by AB for ASCA Recognition (subsequent 1 1 1 6....................................... 6
to withdrawal).
Request by AB to expand scope of ASCA 1 1 1 6....................................... 6
Recognition.
AB annual status report....................... 8 1 8 3....................................... 24
AB notification of change..................... 8 1 8 1....................................... 8
Application by TL for ASCA Accreditation...... 150 1 150 4....................................... 600
Request by TL to continue ASCA Accreditation.. 75 1 75 4....................................... 300
Request by TL for ASCA Accreditation 5 1 5 4....................................... 20
(subsequent to withdrawal or suspension).
Request by TL to expand scope of ASCA 75 1 75 4....................................... 300
Accreditation.
TL annual status report....................... 150 1 150 1.5..................................... 225
TL notification of change..................... 5 1 5 1....................................... 5
Request for withdrawal or suspension of ASCA 6 1 6 0.08 (5 minutes)........................ 1
Accreditation (TLs) or request for withdrawal
of ASCA Recognition (ABs).
Pilot feedback questionnaire (ABs and TLs).... 158 1 158 0.5 (30 minutes)........................ 79
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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
Activity Number of disclosures per Total annual Average burden per disclosure Total hours
respondents respondent disclosures
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Request for Accreditation (TLs requesting 150 1 150 0.5 (30 minutes)........................ 75
accreditation from ABs).
Review/Acknowledgement of accreditation 8 22 176 40...................................... 7,040
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.

[[Page 3422]]

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
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 average burden per 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 (Request by AB to continue
ASCA Recognition and Request by TL to continue ASCA Accreditation)
since the pilot program was initiated.

Dated: January 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00973 Filed 1-18-23; 8:45 am]
BILLING CODE 4164-01-P

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