Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation Scheme for Conformity Assessment Program, 42076-42079 [2023-13860]
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Federal Register / Vol. 88, No. 124 / Thursday, June 29, 2023 / Notices
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: 42 U.S.C. 666(a)(5)(C) and
652(a)(7).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–13855 Filed 6–28–23; 8:45 am]
BILLING CODE 4184–41–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Tribal Consultation Meetings
Office of Head Start (OHS),
Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS).
ACTION: Notice of meetings.
AGENCY:
Pursuant to the Head Start
Act, notice is hereby given of two tribal
consultation sessions to be held
between HHS/ACF OHS leadership and
the leadership of tribal governments
operating Head Start and Early Head
Start programs. The purpose of these
consultation sessions is to discuss ways
to better meet the needs of American
Indian and Alaska Native (AI/AN)
children and their families, taking into
consideration funding allocations,
distribution formulas, and other issues
affecting the delivery of Head Start
services in their geographic locations.
Two tribal consultations will be held as
part of HHS/ACF or ACF Tribal
Consultation Sessions.
DATES:
Wednesday, September 13, 2023
Tuesday, December 5, 2023
ADDRESSES:
• September 13, 2023—1–4 p.m. ET
(Virtual)
• December 5, 2023—2–5 p.m. PT
(Hilton Costa Mesa, 3050 Bristol
Street, Costa Mesa, CA 92626)
FOR FURTHER INFORMATION CONTACT:
Todd Lertjuntharangool, Regional
Program Manager, Region XI/AIAN,
Office of Head Start, email
Todd.Lertjuntharangool@acf.hhs.gov, or
phone (866) 763–6481. Additional
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SUMMARY:
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information and online meeting
registration will be forthcoming.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In
accordance with section 640(l)(4) of the
Head Start Act, 42 U.S.C. 9835(1)(4),
ACF announces OHS Tribal
Consultation Sessions for leaders of
tribal governments operating Head Start
and Early Head Start programs.
The agenda for the scheduled OHS
Tribal Consultations reflects the
statutory purposes of Head Start tribal
consultations related to meeting the
needs of AI/AN children and families.
OHS will also highlight the progress
made in addressing issues and concerns
raised in the previous OHS Tribal
Consultations.
The consultation sessions include
elected or appointed leaders of Tribal
governments and their designated
representatives. Designees must have a
letter from the Tribal government
authorizing them to represent the Tribe.
Tribal governments must submit the
designee letter at least 3 days before the
consultation sessions to Todd
Lertjuntharangool at
Todd.Lertjuntharangool@acf.hhs.gov.
Other representatives of tribal
organizations and Native nonprofit
organizations are welcome to attend as
observers.
Within 45 days of the consultation
sessions, a detailed report of each
consultation session will be available
for all tribal governments receiving
funds for Head Start and Early Head
Start programs. Tribes can submit
written testimony for the report to Todd
Lertjuntharangool at
Todd.Lertjuntharangool@acf.hhs.gov
prior to each consultation session or
within 30 days of each meeting. OHS
will summarize oral testimony and
comments from the consultation
sessions in each report without
attribution, along with topics of concern
and recommendations.
Food and Drug Administration
SUPPLEMENTARY INFORMATION:
Megan E. Steel,
ACF Certifying Officer.
[FR Doc. 2023–13793 Filed 6–28–23; 8:45 am]
BILLING CODE 4184–40–P
PO 00000
[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.
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.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
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.
ADDRESSES:
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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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
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Federal Register / Vol. 88, No. 124 / Thursday, June 29, 2023 / Notices
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 FDArecognized 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
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.
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
1 See
section 514(d)(1)(B) of the FD&C Act.
section 514(d)(2)(A) of the FD&C Act.
3 See section 514(d)(2)(A)–(B) of the FD&C Act.
4 See Public Law 117–180, section 2005.
2 See
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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.
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, ASCArecognized 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. ASCAaccredited 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 ASCAaccredited 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
5 See also MDUFA V Commitment Letter: https://
www.fda.gov/media/158308/download.
6 See CDRH Proposed Guidances for Fiscal Year
2023, B-list: https://www.fda.gov/medical-devices/
guidance-documents-medical-devices-andradiation-emitting-products/cdrh-proposedguidances-fiscal-year-2023-fy2023#b.
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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
7 The Accreditation Scheme for Conformity
Assessment (ASCA) Pilot Program (https://
www.fda.gov/regulatory-information/search-fdaguidance-documents/accreditation-schemeconformity-assessment-asca-pilot-program). 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
(https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/basic-safety-andessential-performance-medical-electricalequipment-medical-electrical-systems-and).
Biocompatibility Testing of Medical Devices—
Standards Specific Information for the
Accreditation Scheme for Conformity Assessment
(ASCA) Pilot Program (https://www.fda.gov/
regulatory-information/search-fda-guidancedocuments/biocompatibility-testing-medicaldevices-standards-specific-informationaccreditation-scheme).
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Federal Register / Vol. 88, No. 124 / Thursday, June 29, 2023 / Notices
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.
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 60day 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
Application by AB for ASCA Recognition ............................
Request by AB to continue ASCA Recognition ..................
Request by AB for ASCA Recognition (subsequent to
withdrawal).
Request by AB to expand scope of ASCA Recognition .....
AB annual status report .......................................................
AB notification of change ....................................................
Application by TL for ASCA Accreditation ..........................
Request by TL to continue ASCA Accreditation .................
Request by TL for ASCA Accreditation (subsequent to
withdrawal or suspension).
Request by TL to expand scope of ASCA Accreditation ....
TL annual status report .......................................................
TL notification of change .....................................................
Request for withdrawal or suspension of ASCA Accreditation (TLs) or request for withdrawal of ASCA Recognition (ABs).
Feedback questionnaire (ABs and TLs) ..............................
Total ..............................................................................
1 Totals
2 There
Number of
responses per
respondent
Number of
respondents
Activity
Average
burden per
response
Total annual
responses
Total hours 2
8
2
1
1
1
1
8
2
1
6 .....................
6 .....................
6 .....................
48
12
6
1
8
8
150
75
5
1
1
1
1
1
1
1
8
8
150
75
5
6
3
1
4
4
4
.....................
.....................
.....................
.....................
.....................
.....................
6
24
8
600
300
20
75
150
5
6
1
1
1
1
75
150
5
6
4 .....................
1.5 ..................
1 .....................
0.08 (5 minutes).
300
225
5
1
158
1
158
0.5 (30 minutes).
........................
........................
........................
79
........................
1,634
have been rounded to the nearest hour.
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
AB setup documentation standard operating procedures
(SOPs) & training (one-time burden) ...............................
TL setup documentation SOPs & training (one-time burden) ..................................................................................
AB record maintenance .......................................................
TL record maintenance ........................................................
3
1
3
25
75
20
8
150
1
1
1
20
8
150
25
1
1
500
8
150
Total ..............................................................................
........................
........................
........................
........................
733
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
Number of
respondents
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Activity
Number of
disclosures
per
respondent
Total annual
disclosures
Request for Accreditation (TLs requesting accreditation
from ABs).
Review/Acknowledgement of accreditation request (ABs)
Test Reports (TLs) ..............................................................
150
1
150
8
880
22
1
Total ..............................................................................
........................
........................
1 There
Average
burden per
disclosure
Total hours
176
880
0.5 (30 minutes).
40 ...................
1 .....................
75
7,040
880
........................
........................
7,995
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
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approximately 150 testing labs will seek
ASCA Accreditation. Our estimate of
Test Reports is based on the number of
premarket submissions we expect per
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year with testing from an ASCAaccredited testing laboratory.
Our estimates for the number of
respondents and average burden per
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Federal Register / Vol. 88, No. 124 / Thursday, June 29, 2023 / Notices
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
FDA Advisory Committee Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0366]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food and Drug
Administration Advisory Committee
Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:21 Jun 28, 2023
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
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 0910–0833. Also include
the FDA docket number found in
brackets in the heading of this
document.
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, PRAStaff@
fda.hhs.gov.
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.
Jkt 259001
OMB Control No. 0910–0833—Revision
This information collection helps
support implementation of FDA
regulations found in part 14 (21 CFR
part 14). These regulations govern
procedures applicable to presenting
information and views before an FDA
advisory committee in accordance with
the Federal Advisory Committee Act
(FACA) (5 U.S.C. App. 2 and 3, Pub. L.
92–463). FACA is designed to assure
that Congress and the public are kept
informed with respect to the purpose,
membership, and activities of advisory
committees. It does not specify the
manner in which advisory committee
members and staff must be appointed.
Public advisory committee regulations
in part 14 set forth requirements
governing the administrative procedures
to follow for the operation of advisory
committees. Agency regulations in part
14, subpart A (§§ 14.1 through 14.15)
identify scope of coverage, applicable
definitions, and establish general
provisions. The regulations in part 14,
subpart B (§§ 14.20 through 14.39) set
forth content and format requirements
along with required schedules for
submission of information. The
regulations in part 14 subparts C, D, and
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42079
E (§§ 14.40 through 14.95) set forth
requirements governing advisory
committee establishment,
recordkeeping, and maintenance,
respectively.
FDA will also require that nominees
to serve on advisory committees submit
a consent form authorizing FDA to post,
without removing or redacting any
information, to FDA’s public website
(https://www.fda.gov/
AdvisoryCommittees) the curriculum
vitae (CV) submitted as part of their
nomination materials if the nominee is
selected to serve on an advisory
committee. The consent form requires
that the nominee affirm that the CV does
not include any confidential
information, including information
pertaining to third parties, that the
nominee is not permitted to disclose. A
nominee will be required to submit a
signed consent form as a part of the
nomination package for the nomination
to be considered complete.
All nominations for new advisory
committee members will be required to
be submitted through FDA’s website at
https://accessdata.test.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm, or
any successor system, and the
submission will be required to be
accompanied by the consent form, on or
after the date of OMB approval for this
information collection. Although we are
developing collection instruments, as
communicated on our website,
respondents may submit information to:
Advisory Committee Oversight and
Management Staff, Office of the
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Silver Spring, MD 20993,
800–741–8138 or 301–443–0572.
In the Federal Register of February
13, 2023 (88 FR 9294), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. Four comments were
received but were not responsive to the
information collection topics solicited
under the PRA. On our own initiative,
we are clarifying the scope of coverage
for the information collections.
We estimate the burden of the
collection of information as follows:
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]]>Agencies
[Federal Register Volume 88, Number 124 (Thursday, June 29, 2023)]
[Notices]
[Pages 42076-42079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13860]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.reginfo.gov/public/do/PRAMain. 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,
[email protected].
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\
---------------------------------------------------------------------------
\1\ See section 514(d)(1)(B) of the FD&C Act.
\2\ See section 514(d)(2)(A) of the FD&C Act.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\3\ See section 514(d)(2)(A)-(B) of the FD&C Act.
---------------------------------------------------------------------------
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: https://www.fda.gov/media/158308/download.
\6\ See CDRH Proposed Guidances for Fiscal Year 2023, B-list:
https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidances-fiscal-year-2023-fy2023#b.
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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
[[Page 42078]]
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 (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/accreditation-scheme-conformity-assessment-asca-pilot-program). 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
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/basic-safety-and-essential-performance-medical-electrical-equipment-medical-electrical-systems-and). Biocompatibility Testing
of Medical Devices--Standards Specific Information for the
Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/biocompatibility-testing-medical-devices-standards-specific-information-accreditation-scheme).
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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\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per Total hours
respondents respondent responses response \2\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual Average burden per
Activity respondents per disclosures disclosure Total hours
respondent
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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
