[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
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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,
[email protected].
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
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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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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