Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation Scheme for Conformity Assessment Pilot Program, 23521-23523 [2020-08989]
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Federal Register / Vol. 85, No. 82 / Tuesday, April 28, 2020 / Notices
• NABP agreement or policies for
voluntary and involuntary termination
of the HIT AO program.
• NABP’s policies and procedures to
avoid conflicts of interest, including the
appearance of conflicts of interest,
involving individuals who conduct
surveys or participate in accreditation
decisions.
IV. Collection of Information
Requirements
This document does not impose
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recordkeeping or third party disclosure
requirements. Consequently, there is no
need for review by the Office of
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authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq).
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The Administrator of the Centers for
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Register.
Dated: April 14, 2020.
Evell J. Barco Holland,
Federal Register Liaison, Department of
Health and Human Services.
[FR Doc. 2020–08990 Filed 4–27–20; 8:45 am]
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.
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.
SUMMARY:
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.
ADDRESSES:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Accreditation Scheme for Conformity
Assessment (ASCA) Pilot Program
OMB Control Number 0910–NEW
BILLING CODE 4120–01–P
jbell on DSKJLSW7X2PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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
1 See
VerDate Sep<11>2014
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Pub. L. 115–52, section 205.
Frm 00021
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Sfmt 4703
23521
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
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
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
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 decision2 See
section 514(d)(1)(B) of the FD&C Act.
section 514(d)(2)(A) of the FD&C Act.
4 See section 514(d)(2)(A) and (B) of the FD&C
Act.
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.
3 See
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28APN1
23522
Federal Register / Vol. 85, No. 82 / Tuesday, April 28, 2020 / Notices
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. ASCAaccredited 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 ASCAaccredited 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 ASCAaccredited 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 ASCAaccredited 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
jbell on DSKJLSW7X2PROD with NOTICES
Application by AB for ASCA recognition .............................
Request by AB to continue recognition ...............................
Request by AB for recognition (subsequent to withdrawal)
Request by AB to expand scope of recognition ..................
AB annual status report .......................................................
AB notification of change .....................................................
Application by TL for ASCA Accreditation ...........................
Request by TL to continue ASCA Accreditation .................
Request by TL for ASCA Accreditation (subsequent to
withdrawal or suspension) ................................................
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Number of
responses per
respondent
Number of
respondents
Activity
PO 00000
Frm 00022
Fmt 4703
Average
burden per
response
(hours)
Total annual
responses
Total hours 2
8
1
1
1
8
8
150
15
1
1
1
1
1
1
1
1
8
1
1
1
8
8
150
15
6
6
6
6
3
1
4
4
48
6
6
6
24
8
600
60
5
1
5
4
20
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28APN1
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Federal Register / Vol. 85, No. 82 / Tuesday, April 28, 2020 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
responses per
respondent
Number of
respondents
Activity
Average
burden per
response
(hours)
Total annual
responses
Total hours 2
Request by TL to expand scope of ASCA accreditation .....
TL annual status report ........................................................
TL notification of change .....................................................
Request for withdrawal or suspension of ASCA Accreditation (TLs) or request for withdrawal of recognition (ABs)
75
150
5
1
1
1
75
150
5
4
1.5
1
300
225
5
6
1
6
1
Pilot feedback questionnaire (ABs and TLs) .......................
158
1
158
0.08 (5
minutes)
0.5 (30
minutes)
Total ..............................................................................
........................
........................
........................
79
........................
1,388
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
Number of
recordkeepers
Activity
Number of
records per
recordkeeper
Average
burden per
recordkeeping
(hours)
Total annual
records
Total hours
AB setup documentation (standard operating procedures
(SOPs)) and training (one-time burden) ..........................
TL setup documentation (SOPs) and training (one-time
burden) .............................................................................
AB record maintenance .......................................................
TL record maintenance ........................................................
8
1
8
25
200
150
8
150
1
1
1
150
8
150
25
1
1
3,750
8
150
Total ..............................................................................
........................
........................
........................
........................
4,108
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
Number of
respondents
Activity
Total annual
disclosures
Request for Accreditation (TLs requesting accreditation
from ABs) .........................................................................
150
1
150
Review/Acknowledgement of accreditation request (ABs) ..
Test Report (TLs) .................................................................
8
880
22
1
Total ..............................................................................
........................
........................
1 There
jbell on DSKJLSW7X2PROD with NOTICES
Number of
disclosures
per respondent
Average
burden per
disclosure
(hours)
Total hours
176
880
0.5 (30
minutes)
40
1
75
7,040
880
........................
........................
7,995
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.
VerDate Sep<11>2014
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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
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: The National Health
Service Corps and Nurse Corps
Interest Capture Form, OMB No. 0915–
0337—Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\1\ See Pub. L. 115-52, section 205.
\2\ See section 514(d)(1)(B) of the FD&C Act.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per Total hours
Activity respondents responses per responses response \2\
respondent (hours)
----------------------------------------------------------------------------------------------------------------
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)......
[[Page 23523]]
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)
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,388
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
Activity recordkeepers records per records recordkeeping Total hours
recordkeeper (hours)
----------------------------------------------------------------------------------------------------------------
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
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 4,108
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
Activity respondents disclosures disclosures disclosure Total hours
per respondent (hours)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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
