[Federal Register Volume 88, Number 12 (Thursday, January 19, 2023)]
[Notices]
[Pages 3419-3422]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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 https://www.regulations.gov or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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, 
[email protected].

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'' (https://www.fda.gov/media/130901/download) 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 (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 [verbar] FDA (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 [verbar] FDA (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.
    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