[Federal Register Volume 85, Number 82 (Tuesday, April 28, 2020)]
[Notices]
[Pages 23521-23523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08989]
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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 Pilot 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: Fax written comments on the collection of information by May 28,
2020.
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 title of this
information collection is ``Accreditation Scheme for Conformity
Assessment (ASCA) Pilot Program.'' 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,
[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 (ASCA) Pilot Program
OMB Control Number 0910-NEW
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
``Pilot Accreditation Scheme for Conformity Assessment. \1\ Section
514(d) of the FD&C Act requires 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
testing laboratories so accredited that a device conforms with an
eligible standard included as part of the ASCA Pilot 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.\2\
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\1\ See Pub. L. 115-52, section 205.
\2\ See section 514(d)(1)(B) of the FD&C Act.
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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.\3\ 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 ASCA Accreditation of a testing laboratory or a request
for additional information regarding a specific device.\4\
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\3\ See section 514(d)(2)(A) of the FD&C Act.
\4\ See section 514(d)(2)(A) and (B) of the FD&C Act.
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FDA intends to issue guidance regarding the goals and
implementation of the voluntary Accreditation Scheme for Conformity
Assessment (ASCA) Pilot Program (hereafter referred to as the ASCA
Pilot) in accordance with amendments made to section 514 of the FD&C
Act \5\ by FDARA, and as part of the enactment of the Medical Device
User Fee Amendments of 2017 (MDUFA IV).\6\
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\5\ See section 514(d)(3)(B) of the FD&C Act.
\6\ See also MDUFA IV Commitment Letter: https://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM526395.pdf.
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The establishment of the goals, scope, procedures, and a suitable
framework for the voluntary ASCA Pilot 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
Pilot 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 Pilot does not supplant or alter any other existing statutory or
regulatory requirements governing the decision-
[[Page 23522]]
making process for premarket submissions.
Under the ASCA Pilot'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 Pilot. When an
ASCA-accredited testing laboratory conducts testing under the ASCA
Pilot, it provides both a complete and summary test report to the
device manufacturer. Device manufacturers may choose to use a testing
laboratory participating in the ASCA Pilot to conduct testing for
premarket submissions to FDA. A device manufacturer who uses an ASCA-
accredited testing laboratory to perform testing in accordance with the
provisions of the ASCA Pilot then includes a declaration of conformity
with supplemental documentation (e.g., 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 Pilot and in accordance with the ASCA program
specifications for that standard.
To participate in the ASCA Pilot, accreditation bodies apply to FDA
for recognition. An application includes demonstration that they have
the qualifications for recognition and agreement to terms of
participation. For example, a recognized accreditation body agrees to
attend training, regularly communicate with FDA, and support periodic
FDA audits. When FDA grants recognition, we will identify the scope of
recognition of specific standards and test methods to which the
accreditation body may accredit testing laboratories as part of the
ASCA Pilot.
To participate in the ASCA Pilot, testing laboratories apply to FDA
for ASCA Accreditation. An application includes demonstration that they
have the qualifications for ASCA Accreditation and agreement to terms
of participation. For example, an ASCA-accredited testing laboratory
agrees to attend training, regularly communicate with FDA, and support
periodic FDA audits. When FDA grants ASCA Accreditation, we will
identify the scope of ASCA Accreditation of specific standard and test
methods to which the testing laboratory may conduct testing as part of
the ASCA Pilot.
During the ASCA Pilot, 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 Pilot. FDA's decision to recognize the
accreditation for purposes of the ASCA Pilot is separate and distinct
from any independent decision by the accreditation body with respect to
a testing laboratory for purposes outside of the ASCA Pilot.
The ASCA Pilot does not address specific content for a particular
premarket submission. Collections of information found in FDA
regulations and guidance, associated with premarket submissions, have
been previously approved as follows. The collections of information in
21 CFR part 807, subpart E (premarket notification) have been approved
under OMB control number 0910-0120; the collections of information in
21 CFR part 812 (investigational device exemption) have been approved
under OMB control number 0910-0078; the collections of information in
21 CFR part 814, subparts A through E (premarket approval) have been
approved under OMB control number 0910-0231; the collections of
information in 21 CFR part 814, subpart H (humanitarian device
exemption) have been approved under OMB control number 0910-0332; the
collections of information in the guidance document ``De Novo
Classification Process (Evaluation of Automatic Class III
Designation)'' have been approved under OMB control number 0910-0844;
the collections of information in 21 CFR part 312 (investigational new
drug application) have been approved under OMB control number 0910-
0014; and the collections of information in 21 CFR part 601 (biologics
license application) have been approved under OMB control number 0910-
0338.
Respondents are accreditation bodies (ABs) and testing laboratories
(TLs). In tables 1 through 3, these abbreviations are used.
In the Federal Register of September 5, 2019 (84 FR 46737), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received one comment on the 60-day
notice, but it was not related to the information collection or the
ASCA Pilot Program. We also considered comments received on the draft
guidance entitled ``The Accreditation Scheme for Conformity Assessment
(ASCA) Pilot Program'' (see 84 FR 49741, September 23, 2019). We have
made no changes to the burden estimate as a result of the comments.
However, as a result of comments on the draft guidance and for clarity,
we have updated certain terminology used to describe the ASCA Pilot.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Average
Number of Number of Total annual burden per Total hours
Activity respondents responses per responses response \2\
respondent (hours)
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Application by AB for ASCA 8 1 8 6 48
recognition....................
Request by AB to continue 1 1 1 6 6
recognition....................
Request by AB for recognition 1 1 1 6 6
(subsequent to withdrawal).....
Request by AB to expand scope of 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 150 1 150 4 600
Accreditation..................
Request by TL to continue ASCA 15 1 15 4 60
Accreditation..................
Request by TL for ASCA 5 1 5 4 20
Accreditation (subsequent to
withdrawal or suspension)......
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Request by TL to expand scope of 75 1 75 4 300
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 1
suspension of ASCA minutes)
Accreditation (TLs) or request
for withdrawal of recognition
(ABs)..........................
Pilot feedback questionnaire 158 1 158 0.5 (30 79
(ABs and TLs).................. minutes)
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Total....................... .............. .............. .............. .............. 1,388
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Totals have been rounded to the nearest hour.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Average
Number of Number of Total annual burden per
Activity recordkeepers records per records recordkeeping Total hours
recordkeeper (hours)
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AB setup documentation (standard 8 1 8 25 200
operating procedures (SOPs))
and training (one-time burden).
TL setup documentation (SOPs) 150 1 150 25 3,750
and 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....................... .............. .............. .............. .............. 4,108
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\1\ There are no capital costs or operating and maintenance costs associated with the collection of information.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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Average
Number of Number of Total annual burden per
Activity respondents disclosures disclosures disclosure Total hours
per respondent (hours)
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Request for Accreditation (TLs 150 1 150 0.5 (30 75
requesting accreditation from minutes)
ABs)...........................
Review/Acknowledgement of 8 22 176 40 7,040
accreditation request (ABs)....
Test Report (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 the 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 laboratories 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 as part of the ASCA Pilot Program.
Our estimates for the average burden per response, recordkeeping,
and disclosure are based on the burden for similar programs.
Dated: April 22, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-08989 Filed 4-27-20; 8:45 am]
BILLING CODE 4164-01-P