Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Humanitarian Use Devices, 35098-35099 [05-11861]
Download as PDF
<![CDATA[
35098
Federal Register / Vol. 70, No. 115 / Thursday, June 16, 2005 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
No. of
respondents
Section of the act/basis of burden
Guidance for notifications
No. of responses
per respondent
3
Total annual
responses
1
Hours per
response
3
1
Total
3
1,153
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
These estimates are based on FDA’s
experience with health claims, nutrient
content claims, and other similar
notification procedures that fall under
the agency’s jurisdiction. Because the
claims are based on an authoritative
statement of certain scientific bodies of
the Federal Government or the National
Academy of Sciences or one of its
subdivisions, FDA believes that the
information submitted with a
notification will either be provided as
part of the authoritative statement, or
readily available as part of the scientific
literature to firms wishing to make
claims. Presentation of a supporting
bibliography and a brief balanced
account or analysis of this literature
should be fairly straightforward.
Dated: June 9, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–11860 Filed 6–15–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0216]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices:
Humanitarian Use Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Total hours
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.
VerDate jul<14>2003
15:42 Jun 15, 2005
Jkt 205001
Submit written or electronic
comments on the collection of
information by August 15, 2005.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
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
DATES:
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
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 implements the
humanitarian use device (HUD)
Provision under section 520(m) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360j(m)) and 21 CFR
part 814, subpart H. Under section
520(m) of the act, FDA is authorized to
exempt an HUD from the effectiveness
requirements of sections 514 and 515 of
the act (21 U.S.C. 360d and 360e)
provided that the device do the
following: (1) Is used to treat or
diagnosis 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 the exemption is
granted, and there is no comparable
device, other than another HUD
approved under this exemption,
available to treat or diagnose the disease
or condition; and (3) the device will not
expose patients to an unreasonable or
significant risk of illness or injury, and
the probable benefit to health from
using the device outweighs the risk of
injury or illness from its use, taking into
account the probable risks and benefits
of currently available devices or
alternative forms of treatment.
The information collection will allow
FDA to determine whether to do the
following: (1) Grant HUD designation of
a medical device, (2) exempt a HUD
from the effectiveness requirements in
sections 514 and 515 of the act provided
that the device meets requirements set
forth in section 520(m) of the act, and
(3) grants marketing approval(s) for the
HUD. Failure to collect this information
would prevent FDA from making those
determinations. Also, this information
enables FDA to determine whether the
holder of a HUD is in compliance with
the HUD requirements.
E:\FR\FM\16JNN1.SGM
16JNN1
35099
Federal Register / Vol. 70, No. 115 / Thursday, June 16, 2005 / Notices
Description of Respondents:
Businesses or others for-profit.
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
20
1
20
40
800
814.104
8
1
8
320
2,560
814.106
8
2
16
50
800
814.108
20
1
20
80
1,600
814.116(e)(3)
1
1
1
1
1
814.124(a)
5
1
5
1
5
814.124(b)
1
1
1
2
2
35
1
35
120
4,200
814.126(b)(1)
Total
9,968
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
No. of recordkeepers
Annual frequency per
recordkeeping
35
21 CFR Section
1
814.126(b)(2)
1 There
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N–0441]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Application for Food and Drug
Administration Approval to Market a
New Drug
Food and Drug Administration,
HHS.
ACTION:
Hours per record
35
Total hours
2
70
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 9, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–11861 Filed 6–15–05; 8:45 am]
AGENCY:
Total annual records
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Application for FDA Approval to
Market a New Drug’’ has been approved
by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Karen Nelson, Office of Management
Programs (HFA–250), Food and Drug
VerDate jul<14>2003
15:42 Jun 15, 2005
Jkt 205001
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In the
Federal Register of January 31, 2005 (70
FR 4853), the agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0001. The
approval expires on May 31, 2008. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
Food and Drug Administration
SUPPLEMENTARY INFORMATION:
Dated: June 9, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–11862 Filed 6–15–05; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
[Docket No. 2005N–0208]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Dissemination of
Information on Unapproved/New Uses
for Marketed Drugs, Biologics, and
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
the reporting and recordkeeping
requirements associated with the
dissemination of unapproved or new
E:\FR\FM\16JNN1.SGM
16JNN1
]]>Agencies
[Federal Register Volume 70, Number 115 (Thursday, June 16, 2005)]
[Notices]
[Pages 35098-35099]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-11861]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0216]
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 August 15, 2005.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. 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: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
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 implements the humanitarian use device (HUD)
Provision under section 520(m) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360j(m)) and 21 CFR part 814, subpart H. Under
section 520(m) of the act, FDA is authorized to exempt an HUD from the
effectiveness requirements of sections 514 and 515 of the act (21
U.S.C. 360d and 360e) provided that the device do the following: (1) Is
used to treat or diagnosis 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 the exemption is
granted, and there is no comparable device, other than another HUD
approved under this exemption, available to treat or diagnose the
disease or condition; and (3) the device will not expose patients to an
unreasonable or significant risk of illness or injury, and the probable
benefit to health from using the device outweighs the risk of injury or
illness from its use, taking into account the probable risks and
benefits of currently available devices or alternative forms of
treatment.
The information collection will allow FDA to determine whether to
do the following: (1) Grant HUD designation of a medical device, (2)
exempt a HUD from the effectiveness requirements in sections 514 and
515 of the act provided that the device meets requirements set forth in
section 520(m) of the act, and (3) grants marketing approval(s) for the
HUD. Failure to collect this information would prevent FDA from making
those determinations. Also, this information enables FDA to determine
whether the holder of a HUD is in compliance with the HUD requirements.
[[Page 35099]]
Description of Respondents: Businesses or others for-profit.
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 20 1 20 40 800
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.104 8 1 8 320 2,560
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.106 8 2 16 50 800
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.108 20 1 20 80 1,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.116(e)(3) 1 1 1 1 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.124(a) 5 1 5 1 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.124(b) 1 1 1 2 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.126(b)(1) 35 1 35 120 4,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total .................... .................... .................... .................... 9,968
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
21 CFR Annual frequency per
Section No. of recordkeepers recordkeeping Total annual records Hours per record Total hours
----------------------------------------------------------------------------------------------------------------
814.126( 35 1 35 2 70
b)(2)
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: June 9, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-11861 Filed 6-15-05; 8:45 am]
BILLING CODE 4160-01-S
