[Federal Register Volume 84, Number 172 (Thursday, September 5, 2019)]
[Notices]
[Pages 46737-46740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19102]


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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 Pilot 
Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) 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, 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) Pilot Program.

DATES: Submit either electronic or written comments on the collection 
of information by November 4, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before November 4, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 4, 2019. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is 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 (ASCA) Pilot 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.
     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

[[Page 46738]]

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.gpo.gov/fdsys/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.

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: Under the PRA (44 U.S.C. 3501-3520), 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, 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 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 (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 Public Law 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 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)-(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 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 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 Pilot 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 Pilot and in accordance with the ASCA Pilot program 
specifications for that standard.
    The ASCA Pilot includes participation from accreditation bodies, 
testing laboratories, device manufacturers, and FDA staff. Each of 
these entities plays a critical role in the ASCA Pilot to ensure that 
patients and health care providers have timely and continued access to 
safe, effective, and high-quality medical devices.
    To participate in the ASCA Pilot, accreditation bodies and testing 
laboratories apply to FDA to demonstrate that they have the 
qualifications for their respective roles within the pilot. An 
application includes agreement to terms of participation. For example, 
a participating accreditation body or

[[Page 46739]]

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 Pilot.
    After recognizing a testing laboratory as a participant in the ASCA 
Pilot, FDA will generally grant the testing laboratory ASCA 
Accreditation. 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. Information collections associated with premarket 
submissions have been previously approved.
    This collection also refers to previously approved collections of 
information found in FDA regulations and guidance. 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.
    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  (hours)      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 participation in                  1               1               1  6........................................               6
 ASCA.
Request by AB to participate (subsequent to                 1               1               1  6........................................               6
 withdrawal).
Request by AB to expand scope of                            1               1               1  6........................................               6
 participation.
AB annual status report......................               8               1               8  3........................................              24
AB notification of change....................               8               1               8  1........................................               8
Application by TL for ASCA recognition.......             150               1             150  4........................................             600
Request by TL to continue participation in                 15               1              15  4........................................              60
 ASCA.
Request by TL to participate (subsequent to                 5               1               5  4........................................              20
 withdrawal or suspension).
Request by TL to expand scope of                           75               1              75  4........................................             300
 participation.
TL annual status report......................             150               1             150  1.5......................................             225
TL notification of change....................               5               1               5  1........................................               5
Request for withdrawal (ABs or TLs) or                      6               1               6  0.08 (5 minutes).........................               1
 suspension (TLs) from ASCA program.
Pilot feedback questionnaire (ABs and TLs)...             158               1             158  0.5 (30 minutes).........................              79
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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 burden
                                                                        Number of       Number of       Number of     Total annual         per       Total
                              Activity                                 respondents    recordkeepers    records per       records      recordkeeping  hours
                                                                                                      recordkeeper                       (hours)
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AB setup documentation standard operating procedures (SOPs) and                   8               1               8              25             200
 training (one-time burden)........................................
TL setup documentation (SOPs) and training (one-time burden).......             150               1             150              25           3,750
AB record maintenance..............................................               8               1               8               1               8
TL record maintenance..............................................             150               1             150               1             150
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[[Page 46740]]

 
    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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                                                                  Number of
                                                  Number of      disclosures    Total annual
                   Activity                      respondents         per         disclosures     Average burden  per disclosure (hours)     Total hours
                                                                 respondent
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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 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 (ILAC) signatories in the United 
States 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: August 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19102 Filed 9-4-19; 8:45 am]
 BILLING CODE 4164-01-P


