Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601, 34189-34190 [2019-15161]
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Federal Register / Vol. 84, No. 137 / Wednesday, July 17, 2019 / Notices
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.
Product Jurisdiction: Assignment of
Agency Component for Review of
Premarket Applications—21 CFR Part 3
OMB Control Number 0910–0523—
Extension
This regulation relates to Agency
management and organization and has
two purposes. The first is to implement
section 503(g) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 353(g)), as
added by the Safe Medical Devices Act
of 1990 (Pub. L. 101–629), and amended
by the Medical Device User Fee and
Modernization Act of 2002 (Pub. L. 107–
250), by specifying how FDA will
determine the organizational component
within FDA assigned to have primary
jurisdiction for the premarket review
and regulation of products that are
comprised of any combination of: (1) A
drug and a device; (2) a device and a
biological product; (3) a biological
product and a drug; or (4) a drug, a
device, and a biological product. The
second purpose of this regulation is to
enhance the efficiency of Agency
management and operations by
providing procedures for classifying and
determining which Agency component
is designated to have primary
jurisdiction for any drug, device, or
biological product where such
jurisdiction is unclear or in dispute.
The regulation establishes a
procedure by which an applicant may
obtain an assignment or designation
determination. The regulation requires
that the request include the identity of
the applicant, a comprehensive
description of the product and its
proposed use, and the applicant’s
recommendation as to which Agency
component should have primary
jurisdiction, with an accompanying
statement of reasons. The information
submitted would be used by FDA as the
basis for making the assignment or
designation decision. Most information
required by the regulation is already
required for premarket applications
affecting drugs, devices, biological
products and combination products.
The respondents will be businesses or
other for-profit organizations. FDA
estimates the burden of this collection
of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR part
3 ...........................................................................................
1 There
Dated: July 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15166 Filed 7–16–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0536]
jbell on DSK3GLQ082PROD with NOTICES
61
Total annual
responses
1
61
Average
burden per
response
Total hours
24
1,464
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall decrease of 552 hours and a
corresponding decrease of 23 responses/
records. This adjustment is based on the
number of submissions we received
since the last OMB approval.
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
User Fee Cover Sheet, Form FDA 3601
AGENCY:
Number of
responses per
respondent
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
18:05 Jul 16, 2019
Jkt 247001
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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 August 16,
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 oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0511. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
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 User Fee Cover Sheet,
Form FDA 3601
OMB Control Number 0910–0511—
Extension
The Federal Food, Drug, and Cosmetic
Act, as amended by the Medical Device
User Fee and Modernization Act of 2002
(Pub. L. 107–250), and the Medical
Device User Fee Amendments of 2007
(Title II of the Food and Drug
Administration Amendments Act of
2007), authorizes FDA to collect user
fees for certain medical device
applications. Under this authority,
companies pay a fee for certain new
medical device applications or
supplements submitted to the Agency
for review. Because the submission of
user fees concurrently with applications
E:\FR\FM\17JYN1.SGM
17JYN1
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Federal Register / Vol. 84, No. 137 / Wednesday, July 17, 2019 / Notices
and supplements is required, the review
of an application cannot begin until the
fee is submitted. Form FDA 3601, the
‘‘Medical Device User Fee Cover Sheet,’’
is designed to provide the minimum
necessary information to determine
whether a fee is required for review of
an application, to determine the amount
of the fee required, and to account for
and track user fees. The form provides
a cross-reference between the fees
submitted for an application with the
actual submitted application by using a
unique number tracking system. The
information collected is used by FDA’s
Center for Devices and Radiological
Health and FDA’s Center for Biologics
Evaluation and Research to initiate the
administrative screening of new medical
device applications and supplemental
applications.
The total number of annual responses
is based on the average number of cover
sheet submissions received by FDA in
recent years. The number of received
annual responses includes cover sheets
for applications that were qualified for
small businesses and fee waivers or
reductions. The estimated hours per
response are based on past FDA
experience with the various cover sheet
submissions, and range from 5 to 30
minutes. The hours per response are
based on the average of these estimates
(18 minutes).
In the Federal Register of December
28, 2018 (83 FR 67287), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. One comment was
received.
The comment was generally
supportive of the user fee cover sheet for
medical devices. However, the comment
also noted that there are costs associated
with the preparation of the cover sheet.
The comment did not suggest specific
changes to our cost or hour burden
estimates provided in this information
collection request. We have not changed
our estimates as a result of the
comment.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
FDA Form No.
3601 .............................................................
1 There
Dated: July 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15161 Filed 7–16–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
6,379
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance on
Reagents for Detection of Specific
Novel Influenza A Viruses
Food and Drug Administration,
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.
VerDate Sep<11>2014
18:05 Jul 16, 2019
Jkt 247001
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:
HHS.
SUMMARY:
Fax written comments on the
collection of information by August 16,
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 oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0584. Also
include the FDA docket number found
in brackets in the heading of this
document.
DATES:
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.
[Docket No. FDA–2015–N–3662]
jbell on DSK3GLQ082PROD with NOTICES
1
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
ACTION:
6,379
Average
burden per
response
Total annual
responses
0.30 (18 minutes) ...........
Total hours
1,914
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall increase of 350 hours and a
corresponding increase of 1,165
responses/records. We attribute this
adjustment to an increase in the number
of submissions we received over the last
few years.
AGENCY:
Number of
responses per
respondent
Guidance on Reagents for Detection of
Specific Novel Influenza A Viruses—21
CFR Part 866
OMB Control Number 0910–0584—
Extension
In accordance with section 513 of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360c), FDA
evaluated an application for an in vitro
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
diagnostic device for detection of
influenza subtype H5 (Asian lineage),
commonly known as avian flu. FDA
concluded that this device is properly
classified into class II in accordance
with section 513(a)(1)(B) of the FD&C
Act, because it is a device for which the
general controls by themselves are
insufficient to provide reasonable
assurance of the safety and effectiveness
of the device, but there is sufficient
information to establish special controls
to provide such assurance. The statute
permits FDA to establish as special
controls many different things,
including postmarket surveillance,
development and dissemination of
guidance recommendations, and ‘‘other
appropriate actions as the Secretary
deems necessary’’ (section 513(a)(1)(B)
of the FD&C Act). This information
collection is a measure that FDA
determined to be necessary to provide
reasonable assurance of safety and
effectiveness of reagents for detection of
specific novel influenza A viruses.
FDA issued an order classifying the
H5 (Asian lineage) diagnostic device
into class II on March 22, 2006 (71 FR
14377), establishing the special controls
necessary to provide reasonable
assurance of the safety and effectiveness
of that device and similar future
devices. The new classification was
codified in 21 CFR 866.3332, a
regulation that describes the new
classification for reagents for detection
of specific novel influenza A viruses
and sets forth the special controls that
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17JYN1
]]>Agencies
[Federal Register Volume 84, Number 137 (Wednesday, July 17, 2019)]
[Notices]
[Pages 34189-34190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15161]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0536]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device User
Fee Cover Sheet, Form FDA 3601
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 August
16, 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 0910-0511.
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 User Fee Cover Sheet, Form FDA 3601
OMB Control Number 0910-0511--Extension
The Federal Food, Drug, and Cosmetic Act, as amended by the Medical
Device User Fee and Modernization Act of 2002 (Pub. L. 107-250), and
the Medical Device User Fee Amendments of 2007 (Title II of the Food
and Drug Administration Amendments Act of 2007), authorizes FDA to
collect user fees for certain medical device applications. Under this
authority, companies pay a fee for certain new medical device
applications or supplements submitted to the Agency for review. Because
the submission of user fees concurrently with applications
[[Page 34190]]
and supplements is required, the review of an application cannot begin
until the fee is submitted. Form FDA 3601, the ``Medical Device User
Fee Cover Sheet,'' is designed to provide the minimum necessary
information to determine whether a fee is required for review of an
application, to determine the amount of the fee required, and to
account for and track user fees. The form provides a cross-reference
between the fees submitted for an application with the actual submitted
application by using a unique number tracking system. The information
collected is used by FDA's Center for Devices and Radiological Health
and FDA's Center for Biologics Evaluation and Research to initiate the
administrative screening of new medical device applications and
supplemental applications.
The total number of annual responses is based on the average number
of cover sheet submissions received by FDA in recent years. The number
of received annual responses includes cover sheets for applications
that were qualified for small businesses and fee waivers or reductions.
The estimated hours per response are based on past FDA experience with
the various cover sheet submissions, and range from 5 to 30 minutes.
The hours per response are based on the average of these estimates (18
minutes).
In the Federal Register of December 28, 2018 (83 FR 67287), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received.
The comment was generally supportive of the user fee cover sheet
for medical devices. However, the comment also noted that there are
costs associated with the preparation of the cover sheet. The comment
did not suggest specific changes to our cost or hour burden estimates
provided in this information collection request. We have not changed
our estimates as a result of the comment.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
FDA Form No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
3601.................................... 6,379 1 6,379 0.30 (18 minutes)......................... 1,914
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the information collection reflects an
overall increase of 350 hours and a corresponding increase of 1,165
responses/records. We attribute this adjustment to an increase in the
number of submissions we received over the last few years.
Dated: July 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15161 Filed 7-16-19; 8:45 am]
BILLING CODE 4164-01-P
