[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, 
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.

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


