Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User Fee Cover Sheet, Form FDA 3601a, 49542-49543 [2021-19113]
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Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices
assume wholesale distributors will
expend 1 hour for each notification.
Because the extent of distribution of
any illegitimate product will vary, we
assume a wide distribution for each
illegitimate product for purposes of
establishing our burden estimate. We
estimate that, for each notification that
a manufacturer or repackager makes to
FDA, the manufacturer or repackager
will notify approximately 30 trading
partners (relying on the number of
distributors). This formula results in
approximately 3,000 notifications
annually to trading partners of
manufacturers and repackagers. This
estimate includes the notifications by
manufacturers and repackagers who
have determined that an illegitimate
product is in their possession or control,
as well as notifications by
manufacturers who have determined
that a product poses a high risk of
illegitimacy.
We assume that a large wholesale
distributor may have up to 4,500 trading
partners, where a small wholesale
distributor may have 200 trading
partners, averaging approximately
2,350. We had originally estimated that
a wholesale distributor would notify all
2,350 trading partners for each of the
illegitimate products identified.
However, as a result of our experience
with the collection and informal
feedback from industry, we have
lowered our estimate to reflect that 138
respondents will make 1,175 disclosures
for a total of 162,150 disclosures
annually and that each disclosure will
require approximately 12 minutes, for a
total of 32,430 hours annually.
We estimate that a pharmacy
purchases prescription drugs from an
average of two wholesale distributors.
Therefore, a pharmacy would notify 2
trading partners for each of the 12
illegitimate products identified. This
estimate results in in approximately 24
notifications annually to pharmacy
trading partners.
We estimate that the burden for
notifying trading partners of an
illegitimate product and the number of
trading partners notified will be the
same as the estimates for notification of
termination. The estimated total burden
hours to notify trading partners that the
notification is terminated is
approximately 33,035 hours annually.
We assume a comparable amount of
time is required to provide the
information necessary for requesting to
terminate a notification. The time
required to investigate and resolve an
illegitimate product notification will
vary, but we assume that each
notification will eventually be
terminated. We assume that the number
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of requests for termination of a
notification per year will be the same as
the original number of notifications for
a given year. The estimated total burden
hours to make requests for termination
of notifications to FDA is 250 hours
annually.
Based on communications we have
had with trading partners and
stakeholders since the 2013 enactment
of the DSCSA, we estimate that 20
trading partners or stakeholders will
submit approximately 20 requests for a
waiver, an exception, or an exemption.
Also based on feedback from industry
stakeholders, we estimate that
respondents will expend an average of
80 hours to prepare and submit each
request and to submit any additional
followup information that we may
request. We estimate the total burden as
approximately 1,600 hours.
We estimate that we will receive from
approximately one respondent
approximately one notification or other
information informing us that there has
or has not been a material change in the
circumstances that warranted the
waiver, exception, or exemption and
that each notification will require
approximately 16 hours to prepare and
submit to us. We estimate the total
burden as approximately 16 hours.
We estimate that we will receive
approximately one renewal request from
approximately one respondent and that
each request will require approximately
16 hours to prepare and submit to us.
We estimate the total burden as
approximately 16 hours.
Our estimated burden for the
information collection reflects an
overall increase of 56,116 hours and a
corresponding increase of 271,638
responses annually. We attribute this
adjustment to an increase in the number
of illegitimate product notification
submissions we received in the last
couple of years and the number of such
submissions we have received so far this
fiscal year.
Dated: August 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–19061 Filed 9–2–21; 8:45 am]
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
and Device Facility User Fee Cover
Sheet, Form FDA 3601a
AGENCY:
Food and Drug Administration,
HHS.
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: Submit written comments
(including recommendations) on the
collection of information by October 4,
2021.
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 OMB
control number for this information
collection is 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
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 and Device Facility
User Fee Cover Sheet, Form FDA 3601a
OMB Control Number 0910–0511—
Revision
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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
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Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices
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
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.
We are revising the information
collection to add Form FDA 3601a, the
‘‘Device Facility User Fee Cover Sheet.’’
Owners or operators of places of
business (also called establishments or
facilities) that are involved in the
production and distribution of medical
devices intended for use in the United
States are required to register annually
with FDA, a process known as
establishment registration (21 CFR part
807, subparts A through D). (The
information collection for medical
device establishment registration and
listing is approved under OMB control
number 0910–0625.) All establishments
required to register must pay a user fee.
Form FDA 3601a, the ‘‘Device Facility
User Fee Cover Sheet,’’ is designed to
collect payments for the annual
establishment registration fee for
medical device establishments.
The total number of annual responses
for Form FDA 3601 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
49543
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. For this analysis, we estimate
18 minutes per coversheet.
The total number of annual responses
for Form FDA 3601a is based on the
average number of cover sheet
submissions received by FDA in recent
years. Based on past FDA experience
with various cover sheet submissions,
we estimate 10 minutes per response.
In the Federal Register of June 12,
2020 (85 FR 35939), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Although two comments
were received, only one was responsive
to the four collection of information
topics solicited.
FDA’s response to the comment is
that the establishment registration fee is
not eligible for a reduced small business
fee. This can be found on our website
at: https://www.fda.gov/medicaldevices/how-study-and-market-yourdevice/device-registration-and-listing.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2
Number of
responses
per
respondent
Number of
respondents
FDA Form No.
Total annual
responses
Average burden
per response
Total hours
3601 .........................................................................
3601a .......................................................................
6,182
24,086
1
1
6,182
24,086
0.30 (18 minutes) ......
0.17 (10 minutes) ......
1,855
4,095
Total ..................................................................
........................
........................
30,268
....................................
5,950
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
have been rounded.
2 Numbers
Our estimated burden for the
information collection reflects an
overall increase of 4,036 hours and a
corresponding increase of 23,889
responses/records. We attribute these
increases to two factors: We have
revised the burden estimate to include
Form FDA 3601a and we have adjusted
the number of respondents for Form
FDA 3601 to reflect our current data.
Dated: August 31, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
lotter on DSK11XQN23PROD with NOTICES1
[FR Doc. 2021–19113 Filed 9–2–21; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
[Docket No. FDA–2018–N–1857]
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive
Controls for Human Food, and Current
Good Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive
Controls for Food for Animals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing that a proposed collection
SUMMARY:
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Submit written comments
(including recommendations) on the
collection of information by October 4,
2021.
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 OMB
control number for this information
collection is 0910–0751. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
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]]>Agencies
[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Notices]
[Pages 49542-49543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19113]
-----------------------------------------------------------------------
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 and Device Facility User Fee Cover
Sheet, Form FDA 3601a
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: Submit written comments (including recommendations) on the
collection of information by October 4, 2021.
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 OMB control number for
this information collection is 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 and Device Facility
User Fee Cover Sheet, Form FDA 3601a
OMB Control Number 0910-0511--Revision
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
[[Page 49543]]
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 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.
We are revising the information collection to add Form FDA 3601a,
the ``Device Facility User Fee Cover Sheet.'' Owners or operators of
places of business (also called establishments or facilities) that are
involved in the production and distribution of medical devices intended
for use in the United States are required to register annually with
FDA, a process known as establishment registration (21 CFR part 807,
subparts A through D). (The information collection for medical device
establishment registration and listing is approved under OMB control
number 0910-0625.) All establishments required to register must pay a
user fee. Form FDA 3601a, the ``Device Facility User Fee Cover Sheet,''
is designed to collect payments for the annual establishment
registration fee for medical device establishments.
The total number of annual responses for Form FDA 3601 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. For this analysis, we estimate 18 minutes per
coversheet.
The total number of annual responses for Form FDA 3601a is based on
the average number of cover sheet submissions received by FDA in recent
years. Based on past FDA experience with various cover sheet
submissions, we estimate 10 minutes per response.
In the Federal Register of June 12, 2020 (85 FR 35939), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although two comments were received, only
one was responsive to the four collection of information topics
solicited.
FDA's response to the comment is that the establishment
registration fee is not eligible for a reduced small business fee. This
can be found on our website at: https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
FDA Form No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
3601........................................ 6,182 1 6,182 0.30 (18 minutes)......................... 1,855
3601a....................................... 24,086 1 24,086 0.17 (10 minutes)......................... 4,095
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. 30,268 .......................................... 5,950
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.
Our estimated burden for the information collection reflects an
overall increase of 4,036 hours and a corresponding increase of 23,889
responses/records. We attribute these increases to two factors: We have
revised the burden estimate to include Form FDA 3601a and we have
adjusted the number of respondents for Form FDA 3601 to reflect our
current data.
Dated: August 31, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19113 Filed 9-2-21; 8:45 am]
BILLING CODE 4164-01-P
