Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Accessories, 40067-40068 [2019-17346]
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40067
Federal Register / Vol. 84, No. 156 / Tuesday, August 13, 2019 / Notices
for one to five years). Cooperative
agreements may have only a few funded
recipients or more than 50 (such as
when a CDC program provides funding
to all states and territories).
To monitor the performance of
recipients and CDC programs toward
achieving outcomes specified by
cooperative agreements, CDC currently
uses the PPMR (OMB Control Number0920–1132, Expiration Date: 08/31/
2019), a progress report form adapted
from an information collection owned
by the Administration for Children and
Families (ACF). This tool may be used
to collect information periodically from
recipients of CDC funds regarding the
progress made on CDC funded projects.
The Performance Measures Project
will work with up to 25 CDC programs
developing cooperative agreements to
address the challenges they face with
performance planning, measurement
and monitoring. Each cooperative
agreement will provide funding to an
average of 35 local entities, for a total of
up to 875 locally funded entities.
Through participation in this Project,
CDC programs and recipients of
cooperative agreement funds will: (1)
Develop strong performance
measurement systems and practices; (2)
define and operationalize priority
performance measures tailored to a
specific cooperative agreement; and (3)
establish common data collection and
reporting expectations across all
recipients for a specific cooperative
agreement. The Project focuses on
addressing these issues during the early
stages of cooperative agreement
development and implementation.
The Project proposes a generic
clearance adapted from a previously
approved generic clearance (OMB
Control Number: 0970–0490, Expiration
Date 1/31/2020) owned by ACF. This
ACF generic clearance replaces the
information collection that is the basis
of CDC’s current PPMR. Project
participants will customize sample
information collections to meet
program-specific needs. The
information collected will enable the
accurate, reliable, uniform and timely
submission to CDC of each recipient’s
progress and performance measures.
The information collected by the
generic information collection is
designed to align with, and support the
goals outlined for each of the CDC
recipients. Collection and reporting of
the information will occur in an
efficient, standardized, and userfriendly manner that will generate a
variety of routine and customizable
reports. The generic information
collection will allow each recipient to
summarize activities and progress
towards meeting performance measures
and goals over a specified time period
specific to each award. CDC will also
have the capacity to generate reports
that describe activities across multiple
recipients. In addition, CDC will use the
information collected to respond to
inquiries from HHS, Congress and other
stakeholder inquiries about program
activities and their impact. CDC
requests OMB approval for three years.
The total estimated burden is 35,000
hours. There is no cost to respondents
other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
CDC Award Recipients ...........
(A) Performance Measures Project Sample Performance
Measure Technical Specification Instrument.
(B) Performance Measures project Sample Performance
Measure Reporting Instrument.
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–17285 Filed 8–12–19; 8:45 am]
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Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
Fax written comments on the
collection of information by September
12, 2019.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0823. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–1593]
jspears on DSK3GMQ082PROD with NOTICES
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
Accessories
AGENCY:
Food and Drug Administration,
FOR FURTHER INFORMATION CONTACT:
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
VerDate Sep<11>2014
17:51 Aug 12, 2019
Jkt 247001
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.
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
875
Number of
responses per
respondent
Average
burden per
response
(in hours)
1
40
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:
Medical Device Accessories
OMB Control Number 0910–0823—
Extension
FDA’s guidance document ‘‘Medical
Device Accessories—Describing
Accessories and Classification
Pathways’’ (the Accessories guidance) 1
is intended to provide guidance to
industry and FDA staff about the
regulation of accessories to medical
devices, to describe FDA’s policy
concerning the classification of
accessories, and to discuss the
application of this policy to devices that
are commonly used as accessories to
other medical devices. In addition, the
guidance explains what devices FDA
1 The guidance document is available on FDA’s
website (https://www.fda.gov/ucm/groups/fdagovpublic/@fdagov-meddev-gen/documents/document/
ucm429672.pdf).
E:\FR\FM\13AUN1.SGM
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40068
Federal Register / Vol. 84, No. 156 / Tuesday, August 13, 2019 / Notices
generally considers an ‘‘accessory’’ and
describes the processes under section
513(f)(6) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
360c(f)(6)) to allow requests for risk- and
regulatory control-based classification of
accessories.
We are requesting OMB approval to
revise this information collection
request (ICR) by adding burden
estimates for two new accessory
classification pathways created by the
FDA Reauthorization Act of 2017
(FDARA) (Pub. L. 115–52).
FDARA changed how FDA regulates
medical device accessories. Specifically,
section 707 of FDARA added section
513(f)(6) to the statute and requires that
FDA, upon request, classify existing and
new accessories notwithstanding the
classification of any other device with
which such accessory is intended to be
used. This means that the classification
of an accessory may not be the same as
its parent device, depending on the risks
of the accessory when used as intended
and the level of regulatory controls
necessary for reasonable assurance of
safety and effectiveness of the accessory.
Until an accessory is distinctly
classified, its existing classification will
continue to apply. This provision does
not preclude a manufacturer from
submitting a De Novo request for an
accessory.
When the Accessories guidance
originally issued, FDA encouraged the
use of the De Novo classification
process to allow manufacturers to
request risk- and regulatory controlbased classification of accessories of a
new type. FDA’s recommendations in
the guidance represented a new
information collection as an accessory
classification De Novo request. The
information collected for an accessory
classification De Novo request is
substantially the same as a De Novo
request (since approved under OMB
control number 0910–0844), is
submitted in the same manner, and has
the same estimated information
collection burden. The burden estimate
associated with ‘‘De Novo request under
21 U.S.C. 513(f)(2)(i)’’ and ‘‘De Novo
request under 21 U.S.C. 513(f)(2)(ii),’’ in
OMB control number 0910–0844,
includes De Novo requests for
accessories. We have determined that
the burden estimate for ‘‘Accessory
Classification De Novo Requests’’ in this
ICR (Accessory Classification Requests;
OMB control number 0910–0823) is
redundant and have, therefore, removed
it.
Depending on an accessory’s
regulatory history, there are different
submission types, tracking mechanisms,
and deadlines:
(1) Existing accessory types are those
that have been identified in a
classification regulation or granted
marketing authorization as part of a
510(k), pre-market application (PMA),
or De Novo request (approved under
OMB control numbers 0910–0120,
0910–0231, and 0910–0844,
respectively). Manufacturers with
marketing authorization for an existing
accessory may request appropriate
classification through a new stand-alone
premarket submission (Existing
Accessory Request). Upon request, FDA
is required to meet with a manufacturer
or importer to discuss the appropriate
classification of an existing accessory
prior to submitting a written request.
Existing Accessory Requests will be
initially tracked as ‘‘Q-submissions’’
(approved under OMB control number
0910–0756). FDA has a statutory
deadline of 85 calendar days to respond
to an Existing Accessory Request.
(2) New accessory types are those that
have not been granted marketing
authorization as part of a 510(k), PMA,
or De Novo request. Manufacturers may
include new accessories into a 510(k) or
PMA with the parent device (New
Accessory Request). New Accessory
Requests will have the same deadline as
the 510(k) or PMA. Therefore, new
accessory types should follow the
applicable Medical Device User Fee
Amendments of 2017 deadline for the
parent submission. The decision for
New Accessory Requests will be
separate from the decision for the
marketing application.
For both Existing and New Accessory
Requests, manufacturers must request
proper classification of their accessory
in the submission and include draft
special controls, if requesting
classification into class II. The processes
that we use to classify an accessory will
be like those used for De Novo requests.
If FDA grants the Accessory Request,
FDA must issue an order establishing a
new classification regulation for the
accessory type. If FDA denies the
Accessory Request, FDA must issue a
letter with a detailed description and
justification for our determination.
In the Federal Register of April 4,
2019 (84 FR 13296), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Total annual
responses
Average
burden per
response
Total hours
Existing Accessory Request ................................................
New Accessory Request ......................................................
15
10
1
1
15
10
40
40
600
400
Total ..............................................................................
........................
........................
........................
........................
1,000
1 There
jspears on DSK3GMQ082PROD with NOTICES
Number of
responses per
respondent
are no capital costs or operating and maintenance costs associated with this collection of information.
We expect to receive approximately
15 Existing Accessory Requests and 10
New Accessory Requests per year. Based
on estimates by FDA administrative and
technical staff who are familiar with the
submission process for accessory
classification requests, we estimate that
the ‘‘Average Burden per Response’’ for
both Existing and New Accessory
Requests will be approximately 40
hours per submission.
VerDate Sep<11>2014
17:51 Aug 12, 2019
Jkt 247001
Our estimated burden for the
information collection reflects an
overall decrease of 440 hours and an
increase of 17 responses. Factors
contributing to the revision of the
burden estimate include the addition of
the two new accessory classification
pathways created by FDARA and the
removal of redundant burden described
earlier in this document.
PO 00000
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Dated: August 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–17346 Filed 8–12–19; 8:45 am]
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]]>Agencies
[Federal Register Volume 84, Number 156 (Tuesday, August 13, 2019)]
[Notices]
[Pages 40067-40068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17346]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-1593]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device
Accessories
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
September 12, 2019.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0823.
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.
Medical Device Accessories
OMB Control Number 0910-0823--Extension
FDA's guidance document ``Medical Device Accessories--Describing
Accessories and Classification Pathways'' (the Accessories guidance)
\1\ is intended to provide guidance to industry and FDA staff about the
regulation of accessories to medical devices, to describe FDA's policy
concerning the classification of accessories, and to discuss the
application of this policy to devices that are commonly used as
accessories to other medical devices. In addition, the guidance
explains what devices FDA
[[Page 40068]]
generally considers an ``accessory'' and describes the processes under
section 513(f)(6) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360c(f)(6)) to allow requests for risk- and regulatory
control-based classification of accessories.
---------------------------------------------------------------------------
\1\ The guidance document is available on FDA's website (https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm429672.pdf).
---------------------------------------------------------------------------
We are requesting OMB approval to revise this information
collection request (ICR) by adding burden estimates for two new
accessory classification pathways created by the FDA Reauthorization
Act of 2017 (FDARA) (Pub. L. 115-52).
FDARA changed how FDA regulates medical device accessories.
Specifically, section 707 of FDARA added section 513(f)(6) to the
statute and requires that FDA, upon request, classify existing and new
accessories notwithstanding the classification of any other device with
which such accessory is intended to be used. This means that the
classification of an accessory may not be the same as its parent
device, depending on the risks of the accessory when used as intended
and the level of regulatory controls necessary for reasonable assurance
of safety and effectiveness of the accessory. Until an accessory is
distinctly classified, its existing classification will continue to
apply. This provision does not preclude a manufacturer from submitting
a De Novo request for an accessory.
When the Accessories guidance originally issued, FDA encouraged the
use of the De Novo classification process to allow manufacturers to
request risk- and regulatory control-based classification of
accessories of a new type. FDA's recommendations in the guidance
represented a new information collection as an accessory classification
De Novo request. The information collected for an accessory
classification De Novo request is substantially the same as a De Novo
request (since approved under OMB control number 0910-0844), is
submitted in the same manner, and has the same estimated information
collection burden. The burden estimate associated with ``De Novo
request under 21 U.S.C. 513(f)(2)(i)'' and ``De Novo request under 21
U.S.C. 513(f)(2)(ii),'' in OMB control number 0910-0844, includes De
Novo requests for accessories. We have determined that the burden
estimate for ``Accessory Classification De Novo Requests'' in this ICR
(Accessory Classification Requests; OMB control number 0910-0823) is
redundant and have, therefore, removed it.
Depending on an accessory's regulatory history, there are different
submission types, tracking mechanisms, and deadlines:
(1) Existing accessory types are those that have been identified in
a classification regulation or granted marketing authorization as part
of a 510(k), pre-market application (PMA), or De Novo request (approved
under OMB control numbers 0910-0120, 0910-0231, and 0910-0844,
respectively). Manufacturers with marketing authorization for an
existing accessory may request appropriate classification through a new
stand-alone premarket submission (Existing Accessory Request). Upon
request, FDA is required to meet with a manufacturer or importer to
discuss the appropriate classification of an existing accessory prior
to submitting a written request. Existing Accessory Requests will be
initially tracked as ``Q-submissions'' (approved under OMB control
number 0910-0756). FDA has a statutory deadline of 85 calendar days to
respond to an Existing Accessory Request.
(2) New accessory types are those that have not been granted
marketing authorization as part of a 510(k), PMA, or De Novo request.
Manufacturers may include new accessories into a 510(k) or PMA with the
parent device (New Accessory Request). New Accessory Requests will have
the same deadline as the 510(k) or PMA. Therefore, new accessory types
should follow the applicable Medical Device User Fee Amendments of 2017
deadline for the parent submission. The decision for New Accessory
Requests will be separate from the decision for the marketing
application.
For both Existing and New Accessory Requests, manufacturers must
request proper classification of their accessory in the submission and
include draft special controls, if requesting classification into class
II. The processes that we use to classify an accessory will be like
those used for De Novo requests. If FDA grants the Accessory Request,
FDA must issue an order establishing a new classification regulation
for the accessory type. If FDA denies the Accessory Request, FDA must
issue a letter with a detailed description and justification for our
determination.
In the Federal Register of April 4, 2019 (84 FR 13296), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Existing Accessory Request...... 15 1 15 40 600
New Accessory Request........... 10 1 10 40 400
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We expect to receive approximately 15 Existing Accessory Requests
and 10 New Accessory Requests per year. Based on estimates by FDA
administrative and technical staff who are familiar with the submission
process for accessory classification requests, we estimate that the
``Average Burden per Response'' for both Existing and New Accessory
Requests will be approximately 40 hours per submission.
Our estimated burden for the information collection reflects an
overall decrease of 440 hours and an increase of 17 responses. Factors
contributing to the revision of the burden estimate include the
addition of the two new accessory classification pathways created by
FDARA and the removal of redundant burden described earlier in this
document.
Dated: August 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17346 Filed 8-12-19; 8:45 am]
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