Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Cover Sheet-Form FDA 3601, 2866-2867 [2010-790]
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2866
Federal Register / Vol. 75, No. 11 / Tuesday, January 19, 2010 / Notices
continue to be counted as part of OMB
Control No. 0910–0284.
The reporting and recordkeeping
burden estimates, including the total
number of annual responses, are based
on the submission of reports to the
Division of Surveillance, Center for
Veterinary Medicine. The annual
frequency of responses was calculated
as the total annual responses divided by
the number of respondents.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section or Section
of the Act
No. of
Respondents
FDA Form No.
514.80(b)(1), (b)(2)(i),
(b)(2)(ii), and (b)(3)
19322
Voluntary reporting FDA
Form 1932a for the public
Annual Frequency
per Response
404
1932a2
44.26
81.5
514.80(b)(4)
2301
2301
84
514.80(b)(5)(ii)
2301
514.80(b)(5)(iii)
2301
Hours per
Response
17,881
1
84
514.80(b)(5)(i)
Total Annual
Responses
1
81.5
17.0
Total Hours
17,881
13
81.5
1,428
16
22,848
0.31
26
2
52
84
33.92
2,849
2
5,698
646
0.08
2
103
51.68
Total hours
46,663.5
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
hours were determined as explained previously.
hours per response for paper versions of Forms FDA 1932 and 1932a are assumed to be 1 hour. The hours per response for the electronic version of Form FDA 1932 is assumed to be 1 hour, while the electronic version of Form FDA 1932a is assumed to take .6 hours to complete the form and gather the required information as part of the MedWatchPlus Portal information collection (see 74 FR 23721 at 23727).
2 Burden
3 The
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
514.80(e)2
Annual Frequency
per Recordkeeping
646
Total Annual
Records
7.20
Hours per
Record
4,651
Total Hours
14
65,116.8
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Section 514.80(e) covers all recordkeeping hours for all adverse event reporting.
Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–782 Filed 1–15–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0483]
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,
jlentini on DSKJ8SOYB1PROD with NOTICES
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
VerDate Nov<24>2008
16:28 Jan 15, 2010
Jkt 220001
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by February
18, 2010.
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 e-mailed 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.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–5156,
Daniel.Gittleson@fda.hhs.gov.
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.
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
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
(Public Law 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 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
E:\FR\FM\19JAN1.SGM
19JAN1
Federal Register / Vol. 75, No. 11 / Tuesday, January 19, 2010 / Notices
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 the Center for
Biologics Evaluation and Research
(CBER) to initiate the administrative
screening of new medical device
applications and supplemental
applications. The total number of
annual responses is based on the
number of cover sheet submissions
received by FDA in fiscal year (FY)
2008. CDRH received approximately
5,095 annual responses that included
the following submissions: 16 premarket
approval applications (PMAs) (PDP,
PMR, and BLA),1 3,625 premarket
notifications, 8 modular premarket
applications, 9 panel track supplements,
201 real-time supplements, 173 180-day
supplements, 633 30-day notices, 93
513(g) requests, and 337 annual fees for
periodic reporting.
CBER received approximately 97
annual responses that included the
following submissions: 2 PMAs, 1 BLA
efficacy supplement, 50 premarket
notifications, 3 180-day supplements, 2
2867
real-time supplements, 20 30-day
notices, 3 513(g) requests, and 16 annual
fees for periodic reporting. The number
of received annual responses in FY 2008
included the 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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Activity
FDA Form No.
No. of Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Medical Device Manufacturers ................
3601
5,192
1
5,192
18/60
1,558
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
In the Federal Register of October 15,
2009 (74 FR 52965), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–790 Filed 1–15–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0465]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food Additive
Petitions
AGENCY:
Food and Drug Administration,
HHS.
jlentini on DSKJ8SOYB1PROD with NOTICES
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 February
18, 2010.
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 e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0546. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
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.
Food Additive Petitions (OMB Control
Number 0910–0546)—Extension
Section 409(a) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 348(a)) provides that a food
additive shall be deemed to be unsafe
unless its use is permitted by a
regulation which prescribes the
condition(s) under which it may safely
be used, or unless it is exempted by
regulation for investigational use.
Section 409(b) of the act specifies the
information that must be submitted by
a petition in order to establish the safety
of a food additive and to secure the
issuance of a regulation permitting its
use.
To implement the provision of section
409 of the act, procedural regulations
have been issued under part 571 (21
CFR part 571). These procedural
regulations are designed to specify more
thoroughly the information that must be
submitted to meet the requirement set
down in broader terms by the law. The
regulations add no substantive
requirements to those indicated in the
law, but seek to explain the
requirements and provide a standard
format for submission of petitions, that
when implemented, will speed up the
time for processing. Labeling
requirements for food additives
intended for animal consumption are
also set forth in various regulations
contained in 21 CFR parts 573, 582, and
584 of the act. The labeling regulations
are considered by FDA to be cross
referenced to § 571.1, which is the
subject of this same OMB clearance for
food additive petitions.
In the Federal Register of October 6,
2009 (74 FR 51287), 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:
1 PDP means product development protocol, PMR
means postmarketing requirements, and BLA means
biologics license applications.
VerDate Nov<24>2008
16:28 Jan 15, 2010
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PO 00000
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Fmt 4703
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19JAN1
]]>Agencies
[Federal Register Volume 75, Number 11 (Tuesday, January 19, 2010)]
[Notices]
[Pages 2866-2867]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-790]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0483]
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) 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
February 18, 2010.
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 e-mailed 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.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
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 (Public Law 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 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
[[Page 2867]]
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 the
Center for Biologics Evaluation and Research (CBER) to initiate the
administrative screening of new medical device applications and
supplemental applications. The total number of annual responses is
based on the number of cover sheet submissions received by FDA in
fiscal year (FY) 2008. CDRH received approximately 5,095 annual
responses that included the following submissions: 16 premarket
approval applications (PMAs) (PDP, PMR, and BLA),\1\ 3,625 premarket
notifications, 8 modular premarket applications, 9 panel track
supplements, 201 real-time supplements, 173 180-day supplements, 633
30-day notices, 93 513(g) requests, and 337 annual fees for periodic
reporting.
---------------------------------------------------------------------------
\1\ PDP means product development protocol, PMR means
postmarketing requirements, and BLA means biologics license
applications.
---------------------------------------------------------------------------
CBER received approximately 97 annual responses that included the
following submissions: 2 PMAs, 1 BLA efficacy supplement, 50 premarket
notifications, 3 180-day supplements, 2 real-time supplements, 20 30-
day notices, 3 513(g) requests, and 16 annual fees for periodic
reporting. The number of received annual responses in FY 2008 included
the 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.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
Activity FDA Form No. No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Manufacturers...................... 3601 5,192 1 5,192 18/60 1,558
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
In the Federal Register of October 15, 2009 (74 FR 52965), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-790 Filed 1-15-10; 8:45 am]
BILLING CODE 4160-01-S
