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 3601a, 76851-76853 [2024-21435]
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lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices
including considerations for vaccine
composition for (H5) vaccines. Under
Topic III, the Committee will hear an
overview of the research programs in
the Laboratory of Pediatric &
Respiratory Viral Diseases and the
Laboratory of DNA Viruses in the
Division of Viral Products, Office of
Vaccines Research and Review, CBER.
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be closed to the public for committee
deliberations.
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material available to the public no later
than 2 business days before the meeting.
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material on its website prior to the
meeting, the background material will
be made publicly available on FDA’s
website at the time of the advisory
committee meeting. Background
material and the link to the online
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meeting will be available at: https://
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the appropriate advisory committee
meeting link. The meeting will include
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Procedure: On October 10, 2024, from
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after October 2, 2024, and by October 9,
2024, will be taken into consideration
by FDA. Oral presentations from the
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requesting to speak is greater than can
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
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The conditions for issuance of a waiver
under 21 CFR 10.19 are met.
Dated: September 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–21431 Filed 9–18–24; 8:45 am]
BILLING CODE 4164–01–P
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76851
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0022]
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 3601a
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: Submit written comments
(including recommendations) on the
collection of information by October 21,
2024.
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
This information collection supports
the FDA medical device and device user
fee programs. The Federal Food, Drug,
and Cosmetic Act (FD&C Act), as
amended by the Medical Device User
Fee and Modernization Act of 2002
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76852
Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices
(MDUFMA) (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 (FDAAA) (Pub. L. 110–85)),
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. Form FDA 3601 and
instructions are available online for
registered users. 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 (CDRH) and FDA’s Center for
establishment must submit notice to
FDA for selection approval (see 21
U.S.C. 374(g)(1) and (g)(6)(B)). Referred
to as the ‘‘Accredited Persons Inspection
Program,’’ FDA publishes a complete
list of accredited persons and the
activities for which they are accredited
on our website at Third Party Device
Inspection,1 along with additional
information about the program.
The guidance document entitled
‘‘FDA and Industry Procedures for
Section 513(g) Requests for Information
under the Federal Food, Drug, and
Cosmetic Act’’ (December 2019) 2
provides FDA’s recommendations
regarding provision of user fees for
513(g) requests for information under
section 738(a)(2)(A)(ix) of the FD&C Act
(21 U.S.C. 379j(a)(2)(A)(ix)). Instructions
for submission and specific content
elements are discussed in the guidance
document in sections IV and V,
respectively.
In the Federal Register of February
29, 2024 (89 FR 14890), 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:
Biologics Evaluation and Research
(CBER) to initiate the administrative
screening of new medical device
applications and supplemental
applications.
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.
Under section 704(g) of the FD&C Act
(21 U.S.C. 374(g)), FDA may accredit
persons to inspect qualified
manufacturers of class II and class III
devices. An eligible establishment is
permitted to select any FDA-accredited
person to conduct an inspection in lieu
of an FDA inspection, but the eligible
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
FDA form or activity
Number of
responses per
respondent
Total
annual
responses
Average burden per
response
Total
hours
User Fee Cover Sheet
Form FDA 3601 (Medical Device User Fee Cover Sheet) ...........
Form FDA 3601a (Device Facility User Fee Cover Sheet) ..........
6,182
24,086
Subtotal ...................................................................................
....................
1
1
6,182
24,086
........................
30,268
I
0.30 (18 minutes) ....
0.17 (10 minutes) ....
I
..................................
1,855
4,095
5,950
Inspection by Accredited Persons Program Under Section 704 of the FD&C Act
Request for accreditation ...............................................................
Notification of the intent to use an Accredited Person ..................
Subtotal ...................................................................................
1
10
I
....................
1
1
I
........................
1
10
I
11
80 .............................
15 .............................
80
150
I
..................................
230
Request for Information Under Section 513(g) of the FD&C Act
Sections IV and V of Guidance; CDRH 513(g) requests ..............
Sections IV and V of Guidance; CBER 513(g) requests ..............
114
4
1
1
114
4
12 .............................
12 .............................
1,368
48
Subtotal ...................................................................................
....................
........................
118
..................................
1,416
Total .................................................................................
lotter on DSK11XQN23PROD with NOTICES1
1 There
I
....................
I
........................
I
....................
are no capital costs or operating and maintenance costs associated with this collection of information.
User Fee Cover Sheet
According to FDA’s database system,
manufacturers of products subject to
1 https://www.fda.gov/medical-devices/
postmarket-requirements-devices/third-partyinspection-devices.
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16:59 Sep 18, 2024
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I
..................................
7,596
MDUFMA submit an average of 6,182
applications annually and submit an
average of 24,086 Device Facility User
Fee applications. However, not all
manufacturers will have any cover sheet
submissions in a given year and some
may have multiple cover sheet
submissions. The estimated hours per
2 https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/fda-and-industry-
procedures-section-513g-requests-informationunder-federal-food-drug-and-cosmetic.
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Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices
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). The total hours are
rounded to the nearest whole number.
lotter on DSK11XQN23PROD with NOTICES1
Inspection by Accredited Persons
Program Under Section 704 of the FD&C
Act
Section 704(g) of the FD&C Act
provides for accreditation of persons for
the purpose of conducting inspections
and provides the minimum
requirements a person must meet to be
accredited to conduct inspections (an
Accredited Person (AP)). The burden
estimate for requests for accreditation is
based on the number of applications
we’ve received. Once an organization is
accredited, it will not be required to
reapply.
The AP Program permits eligible
manufacturers to use APs to perform
certain inspections. While all firms
remain subject to inspection by FDA,
eligible manufacturers have the option
of requesting inspection by an AP. A
device establishment is eligible for
inspection by APs if the establishment
meets certain conditions of section
704(g)(6) of the FD&C Act, including
that they provide notice of their
intention to use an AP to conduct
inspections of the establishment.
We estimate there are 4,000 domestic
manufacturers and 4,000 foreign
manufacturers that are eligible for
inclusion under the AP program. Based
on informal communications with
industry, approximately 10 of these
manufacturers may submit a request to
use an AP in any given year.
Request for Information Under Section
513(g) of the FD&C Act
Respondents may elect to prepare
their 513(g) request for information
using CDRH’s electronic Submission
Template and Resource (eSTAR)
voluntary guided submission
preparation tool, which was developed
to improve submission consistency and
enhance efficiency in the review
process. The total number of annual
responses is based on the average
number of 513(g) requests received each
year by CDRH and CBER respectively.
Based on a review of the information
collection since our last request for
OMB approval, we have made
modifications to our burden estimate. In
our March 2023 change request
submission, we erroneously excluded
the information collection entitled,
‘‘Notification of the intent to use an
Accredited Person.’’ We have included
the information collection activity to
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16:59 Sep 18, 2024
Jkt 262001
this renewal. The information
collection, therefore, reflects a
cumulative increase in burden by 10
annual responses and 150 burden hours.
Dated: September 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–21435 Filed 9–18–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–4167]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Labeling
Requirements for Prescription Drugs
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed revision of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on information
collection associated with labeling
requirements for prescription drugs.
DATES: Either electronic or written
comments on the collection of
information must be submitted by
November 18, 2024.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
November 18, 2024. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
PO 00000
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76853
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include Docket No. FDA–2024–N–
4167 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Labeling
Requirements for Prescription Drugs.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
E:\FR\FM\19SEN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 182 (Thursday, September 19, 2024)]
[Notices]
[Pages 76851-76853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21435]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0022]
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 3601a
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: Submit written comments (including recommendations) on the
collection of information by October 21, 2024.
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
This information collection supports the FDA medical device and
device user fee programs. The Federal Food, Drug, and Cosmetic Act
(FD&C Act), as amended by the Medical Device User Fee and Modernization
Act of 2002
[[Page 76852]]
(MDUFMA) (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 (FDAAA) (Pub. L. 110-85)), 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. Form FDA 3601 and
instructions are available online for registered users. 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 (CDRH) and FDA's Center for
Biologics Evaluation and Research (CBER) to initiate the administrative
screening of new medical device applications and supplemental
applications.
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.
Under section 704(g) of the FD&C Act (21 U.S.C. 374(g)), FDA may
accredit persons to inspect qualified manufacturers of class II and
class III devices. An eligible establishment is permitted to select any
FDA-accredited person to conduct an inspection in lieu of an FDA
inspection, but the eligible establishment must submit notice to FDA
for selection approval (see 21 U.S.C. 374(g)(1) and (g)(6)(B)).
Referred to as the ``Accredited Persons Inspection Program,'' FDA
publishes a complete list of accredited persons and the activities for
which they are accredited on our website at Third Party Device
Inspection,\1\ along with additional information about the program.
---------------------------------------------------------------------------
\1\ https://www.fda.gov/medical-devices/postmarket-requirements-devices/third-party-inspection-devices.
---------------------------------------------------------------------------
The guidance document entitled ``FDA and Industry Procedures for
Section 513(g) Requests for Information under the Federal Food, Drug,
and Cosmetic Act'' (December 2019) \2\ provides FDA's recommendations
regarding provision of user fees for 513(g) requests for information
under section 738(a)(2)(A)(ix) of the FD&C Act (21 U.S.C.
379j(a)(2)(A)(ix)). Instructions for submission and specific content
elements are discussed in the guidance document in sections IV and V,
respectively.
---------------------------------------------------------------------------
\2\ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-procedures-section-513g-requests-information-under-federal-food-drug-and-cosmetic.
---------------------------------------------------------------------------
In the Federal Register of February 29, 2024 (89 FR 14890), 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 Total
FDA form or activity Number of responses per annual Average burden per response Total
respondents respondent responses hours
----------------------------------------------------------------------------------------------------------------
User Fee Cover Sheet
----------------------------------------------------------------------------------------------------------------
Form FDA 3601 (Medical Device 6,182 1 6,182 0.30 (18 minutes)........... 1,855
User Fee Cover Sheet).
Form FDA 3601a (Device Facility 24,086 1 24,086 0.17 (10 minutes)........... 4,095
User Fee Cover Sheet).
--------------------------------------------------------------------------------
Subtotal................... ........... .............. 30,268 ............................ 5,950
----------------------------------------------------------------------------------------------------------------
Inspection by Accredited Persons Program Under Section 704 of the FD&C Act
----------------------------------------------------------------------------------------------------------------
Request for accreditation...... 1 1 1 80.......................... 80
Notification of the intent to 10 1 10 15.......................... 150
use an Accredited Person.
--------------------------------------------------------------------------------
Subtotal................... ........... .............. 11 ............................ 230
----------------------------------------------------------------------------------------------------------------
Request for Information Under Section 513(g) of the FD&C Act
----------------------------------------------------------------------------------------------------------------
Sections IV and V of Guidance; 114 1 114 12.......................... 1,368
CDRH 513(g) requests.
Sections IV and V of Guidance; 4 1 4 12.......................... 48
CBER 513(g) requests.
--------------------------------------------------------------------------------
Subtotal................... ........... .............. 118 ............................ 1,416
--------------------------------------------------------------------------------
Total.................. ........... .............. ........... ............................ 7,596
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
User Fee Cover Sheet
According to FDA's database system, manufacturers of products
subject to MDUFMA submit an average of 6,182 applications annually and
submit an average of 24,086 Device Facility User Fee applications.
However, not all manufacturers will have any cover sheet submissions in
a given year and some may have multiple cover sheet submissions. The
estimated hours per
[[Page 76853]]
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). The total hours
are rounded to the nearest whole number.
Inspection by Accredited Persons Program Under Section 704 of the FD&C
Act
Section 704(g) of the FD&C Act provides for accreditation of
persons for the purpose of conducting inspections and provides the
minimum requirements a person must meet to be accredited to conduct
inspections (an Accredited Person (AP)). The burden estimate for
requests for accreditation is based on the number of applications we've
received. Once an organization is accredited, it will not be required
to reapply.
The AP Program permits eligible manufacturers to use APs to perform
certain inspections. While all firms remain subject to inspection by
FDA, eligible manufacturers have the option of requesting inspection by
an AP. A device establishment is eligible for inspection by APs if the
establishment meets certain conditions of section 704(g)(6) of the FD&C
Act, including that they provide notice of their intention to use an AP
to conduct inspections of the establishment.
We estimate there are 4,000 domestic manufacturers and 4,000
foreign manufacturers that are eligible for inclusion under the AP
program. Based on informal communications with industry, approximately
10 of these manufacturers may submit a request to use an AP in any
given year.
Request for Information Under Section 513(g) of the FD&C Act
Respondents may elect to prepare their 513(g) request for
information using CDRH's electronic Submission Template and Resource
(eSTAR) voluntary guided submission preparation tool, which was
developed to improve submission consistency and enhance efficiency in
the review process. The total number of annual responses is based on
the average number of 513(g) requests received each year by CDRH and
CBER respectively.
Based on a review of the information collection since our last
request for OMB approval, we have made modifications to our burden
estimate. In our March 2023 change request submission, we erroneously
excluded the information collection entitled, ``Notification of the
intent to use an Accredited Person.'' We have included the information
collection activity to this renewal. The information collection,
therefore, reflects a cumulative increase in burden by 10 annual
responses and 150 burden hours.
Dated: September 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21435 Filed 9-18-24; 8:45 am]
BILLING CODE 4164-01-P
