Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Humanitarian Use Devices, 57108-57109 [E8-22991]
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jlentini on PROD1PC65 with NOTICES
57108
Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices
the October through December 2007
timeframe, FDA received fewer than 10
requests for waivers for the requirement
to submit registration and listing
information electronically. As data for
more than 16,000 establishments have
been received electronically for the
same period, these requests amount to
less than 1 percent of the total number
of establishments that have responded.
Based on information taken from our
databases, FDA estimates that there are
29,370 owner/operators who
collectively register a total of 33,490
device establishments. The number of
respondents listed for section 224 of
FDAAA in Table 1 of this document is
29,370, which corresponds to the
number of owner/operators who
annually register one or more
establishments. In addition, FDA
estimates that 4,988 owner/operators are
initial importers who must register their
establishments but who, under FDA’s
existing regulations, are not required to
list their devices unless they initiate or
develop the specifications for the
devices or repackage or relabel the
devices. The number of respondents
included in Table 1 of this document for
section 223 of FDAAA is 24,382, which
corresponds to the number of owner/
operators who annually list one or more
devices (29,370 - 4,988 = 24,382).
To calculate the burden estimate for
waiver requests under section 224 of
FDAAA, we assume as stated
previously, that less than one-tenth of 1
percent of the 33,490 total device
establishments would request waivers
from FDA. This means the total number
of waiver requests would probably not
exceed 20 requests (33,490 x 0.0006).
We also estimate that the one-time
burden on these establishments would
be an hour of time for a mid-level
manager to draft, approve, and mail a
letter. In addition, FDA estimates the
total number of establishments will
increase by 2,600 new establishments
each year. Of the 2,600 new registrants
each year, we assume that less than 1
percent (i.e., 1) of these will also request
waivers each year. The total, therefore,
is 21 waiver requests, which could
increase by only one additional request
each year.
The burden estimate for
recordkeeping requirements under
section 222 of FDAAA in Table 2 of this
document, complies with the
requirement that owners or operators
keep a list of officers, directors, and
partners for each establishment. Owners
or operators will need to provide this
information only upon request from
FDA. However, it is assumed that some
effort will need to be expended for
keeping such lists current.
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The burden estimate for the
recordkeeping requirements under
section 223 of FDAAA in table 2 of this
document reflect other recordkeeping
requirements for devices listed with
FDA, and the requirement to provide
these records upon request from FDA.
These estimates are based on FDA
experience.
Dated: September 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–22989 Filed 9–30–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0512]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices:
Humanitarian Use Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension 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 requirements for
Humanitarian Use Devices.
DATES: Submit written or electronic
comments on the collection of
information by December 1, 2008.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
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.
PO 00000
Frm 00062
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Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
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.
SUPPLEMENTARY INFORMATION:
Medical Devices: Humanitarian Use
Devices—21 CFR Part 814 (OMB
Control Number 0910–0332)—Extension
This collection of information
implements the humanitarian use
device (HUD) provision of section
520(m) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C.
360j(m)) and subpart H, part 814 (21
CFR part 814). Under section 520(m) of
the act, FDA is authorized to exempt a
HUD from the effectiveness
requirements of sections 514 and 515 of
the act (21 U.S.C. 360d and 360e)
provided that the device: (1) Is used to
treat or diagnose a disease or condition
that affects fewer than 4,000 individuals
in the United States; (2) would not be
available to a person with such a disease
or condition unless an exemption is
granted, because there is no comparable
device other than another HUD
approved under this exemption that is
available to treat or diagnose the disease
E:\FR\FM\01OCN1.SGM
01OCN1
57109
Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices
following: (1) Whether to grant HUD
designation of a medical device; (2)
exempt a HUD from the effectiveness
requirements under sections 514 and
515 of the act, provided that the device
meets requirements set forth under
section 520(m) of the act; and (3)
whether to grant marketing approval(s)
for the HUD. Failure to collect this
information would prevent FDA from
or condition; and (3) will not expose
patients to an unreasonable or
significant risk of illness or injury with
the probable benefit to health from
using the device outweighing the risk of
injury or illness from its use. This takes
into account the probable risks and
benefits of currently available devices or
alternative forms of treatment.
The information collected will assist
FDA in making determinations on the
making a determination on the factors
listed previously in this document.
Further, the collected information
would also enable FDA to determine
whether the holder of a HUD is in
compliance with the HUD provisions
under section 520(m) of the act.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
Annual Frequency per
Response
No. of Respondents
Total Annual Responses
Hours per Response
Total Hours
814.102
14
1
14
40
560
814.104
6
1
6
320
1,920
814.106
6
2
12
50
600
814.108
32
1
32
80
2,560
814.116(e)(3)
1
1
1
1
1
814.124(a)
5
1
5
1
5
814.24(b)
4
1
4
2
8
45
1
45
120
5,400
814.126(b)(1)
Total
1 There
11,054
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of Recordkeepers
Annual Frequency per
Recordkeeping
Total Annual Records
45
21 CFR Section
1
45
814.126(b)(2)
Hours per Record
2
Total
jlentini on PROD1PC65 with NOTICES
1 There
Total Hours
90
90
are no capital costs or operating and maintenance costs associated with this collection of information.
The number of respondents in Tables
1 and 2 of this document are an average
from data for the previous 3 years, i.e.,
FY 2005–2007. The number of annual
reports submitted under § 814.126(b)(1)
in Table 1 reflects an increase to 45
respondents with approved HUD
applications. Likewise, under
§ 814.126(b)(2) in Table 2, the number of
recordkeepers increased to 45.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: September 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–22991 Filed 9–30–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0506]
Determination That ATROVENT
(Ipatropium Bromide) Inhalation
Solution and 10 Other Drug Products
Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
VerDate Aug<31>2005
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Notice.
Frm 00063
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SUMMARY: The Food and Drug
Administration (FDA) has determined
that the 11 drug products listed in this
document were not withdrawn from
sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products as long as they
meet relevant legal and regulatory
requirements.
FOR FURTHER INFORMATION CONTACT:
Olivia Pritzlaff, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6308,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
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01OCN1
]]>Agencies
[Federal Register Volume 73, Number 191 (Wednesday, October 1, 2008)]
[Notices]
[Pages 57108-57109]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-22991]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0512]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices: Humanitarian Use Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension 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
requirements for Humanitarian Use Devices.
DATES: Submit written or electronic comments on the collection of
information by December 1, 2008.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this 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.
Medical Devices: Humanitarian Use Devices--21 CFR Part 814 (OMB Control
Number 0910-0332)--Extension
This collection of information implements the humanitarian use
device (HUD) provision of section 520(m) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360j(m)) and subpart H, part 814 (21
CFR part 814). Under section 520(m) of the act, FDA is authorized to
exempt a HUD from the effectiveness requirements of sections 514 and
515 of the act (21 U.S.C. 360d and 360e) provided that the device: (1)
Is used to treat or diagnose a disease or condition that affects fewer
than 4,000 individuals in the United States; (2) would not be available
to a person with such a disease or condition unless an exemption is
granted, because there is no comparable device other than another HUD
approved under this exemption that is available to treat or diagnose
the disease
[[Page 57109]]
or condition; and (3) will not expose patients to an unreasonable or
significant risk of illness or injury with the probable benefit to
health from using the device outweighing the risk of injury or illness
from its use. This takes into account the probable risks and benefits
of currently available devices or alternative forms of treatment.
The information collected will assist FDA in making determinations
on the following: (1) Whether to grant HUD designation of a medical
device; (2) exempt a HUD from the effectiveness requirements under
sections 514 and 515 of the act, provided that the device meets
requirements set forth under section 520(m) of the act; and (3) whether
to grant marketing approval(s) for the HUD. Failure to collect this
information would prevent FDA from making a determination on the
factors listed previously in this document. Further, the collected
information would also enable FDA to determine whether the holder of a
HUD is in compliance with the HUD provisions under section 520(m) of
the act.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency per Total Annual
21 CFR Section No. of Respondents Response Responses Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.102 14 1 14 40 560
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.104 6 1 6 320 1,920
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.106 6 2 12 50 600
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.108 32 1 32 80 2,560
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.116(e)(3) 1 1 1 1 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.124(a) 5 1 5 1 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.24(b) 4 1 4 2 8
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.126(b)(1) 45 1 45 120 5,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 11,054
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency per
21 CFR Section No. of Recordkeepers Recordkeeping Total Annual Records Hours per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.126(b)(2) 45 1 45 2 90
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 90
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The number of respondents in Tables 1 and 2 of this document are an
average from data for the previous 3 years, i.e., FY 2005-2007. The
number of annual reports submitted under Sec. 814.126(b)(1) in Table 1
reflects an increase to 45 respondents with approved HUD applications.
Likewise, under Sec. 814.126(b)(2) in Table 2, the number of
recordkeepers increased to 45.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
Dated: September 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-22991 Filed 9-30-08; 8:45 am]
BILLING CODE 4160-01-S
