Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Humanitarian Use Devices, 76357-76358 [E8-29672]
Download as PDF
<![CDATA[
Federal Register / Vol. 73, No. 242 / Tuesday, December 16, 2008 / Notices
1. The staff memo to the Board will
be made available to the public in paper
and the background material will be
made available on a computer disc in
Word format. If you require a paper
copy of the document, please call
Penelope Beattie on 202–452–3982.
2. This meeting will be recorded for
the benefit of those unable to attend.
Computer discs (CDs) will then be
available for listening in the Board’s
Freedom of Information Office, and
copies can be ordered for $4 per disc by
calling 202–452–3684 or by writing to:
Freedom of Information Office, Board of
Governors of the Federal Reserve
System, Washington, D.C. 20551.
FOR FURTHER INFORMATION CONTACT:
Michelle Smith, Director, or Dave
Skidmore, Assistant to the Board, Office
of Board Members at 202–452–2955.
SUPPLEMENTARY INFORMATION: You may
call 202–452–3206 for a recorded
announcement of this meeting; or you
may contact the Board’s Web site at
https://www.federalreserve.gov for an
electronic announcement. (The Web site
also includes procedural and other
information about the open meeting.)
Board of Governors of the Federal Reserve
System, December 11, 2008.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. E8–29823 Filed 12–12–08; 11:15
am]
BILLING CODE 6210–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–0038]
Advisory Committees; Filing of Closed
Meeting Reports
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that, as required by the Federal
Advisory Committee Act, the agency has
filed with the Library of Congress the
annual reports of those FDA advisory
committees that held closed meetings
during fiscal year 2008.
ADDRESSES: Copies are available from
the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, 301–827–
6860.
Management Officer, Advisory
Committee Oversight and Management
Staff (HF–4), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1220.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Under
section 10(d) of the Federal Advisory
Committee Act (5 U.S.C. app.1) and 21
CFR 14.60(d), FDA has filed with the
Library of Congress the annual reports
for the following FDA advisory
committees that held closed meetings
during the period October 1, 2007,
through September 30, 2008:
Center for Biologics Evaluation and
Research:
Blood Products Advisory Committee,
Cellular, Tissue and Gene Therapies
Advisory Committee,
Vaccines and Related Biological
Products Advisory Committee,
Center for Drugs Evaluation and
Research:
Anesthetic and Life Support Drugs
Advisory Committee,
Oncologic Drugs Advisory Committee,
Center for Devices and Radiological
Health:
Medical Devices Advisory Committee
(consisting of reports for Circulatory
Drugs Devices Panel, Obstetrics and
Gynecology Devices Panel and the
Radiological Devices Panel),
National Center for Toxicological
Research:
Science Board to the National Center
for Toxicological Research.
Annual Reports are available for
public inspections between 9 a.m. and
4 p.m., Monday through Friday at the
following locations:
1. The Library of Congress, Madison
Bldg., Newspaper and Current
Periodical Reading Room, 101
Independence Ave. SE., rm. 133,
Washington, DC; and
2. The Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices:
Humanitarian Use Devices
SUPPLEMENTARY INFORMATION:
Dated: December 9, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–29679 Filed 12–15–08; 8:45 am]
BILLING CODE 4160–01–S
FOR FURTHER INFORMATION CONTACT:
Theresa L. Green, Committee
VerDate Aug<31>2005
17:09 Dec 15, 2008
Jkt 217001
76357
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
Food and Drug Administration
[Docket No. FDA–2008–N–0512]
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 January 15,
2009.
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:
202–395–6974, or e-mailed to
oiralsubmissions@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0332. 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.
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
E:\FR\FM\16DEN1.SGM
16DEN1
76358
Federal Register / Vol. 73, No. 242 / Tuesday, December 16, 2008 / Notices
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
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.
In the Federal Register of October 1,
2008 (73 FR 57108), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
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
814.124(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
21 CFR Section
No. of
Recordkeepers
814.126(b)(2)
Annual Frequency
per Recordkeeping
45
Total Annual
Records
1
Hours Per
Record
45
Total Hours
2
Total
1 There
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.,
fiscal year 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.
sroberts on PROD1PC70 with NOTICES
90
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: December 9, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–29672 Filed 12–15–08; 8:45 am]
HHS.
BILLING CODE 4160–01–S
VerDate Aug<31>2005
17:09 Dec 15, 2008
Jkt 217001
Food and Drug Administration
[Docket No. FDA–2008–N–0633]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Postmarketing
Adverse Drug Experience Reporting
AGENCY:
ACTION:
Food and Drug Administration,
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
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
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
postmarketing adverse drug experience
reporting and recordkeeping
requirements.
DATES: Submit written or electronic
comments on the collection of
information by February 17, 2009.
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
E:\FR\FM\16DEN1.SGM
16DEN1
]]>Agencies
[Federal Register Volume 73, Number 242 (Tuesday, December 16, 2008)]
[Notices]
[Pages 76357-76358]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29672]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0512]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices:
Humanitarian Use Devices
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 January
15, 2009.
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: 202-395-6974, or e-mailed to oira_submissions@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0332.
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.
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
[[Page 76358]]
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 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.
In the Federal Register of October 1, 2008 (73 FR 57108), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours Per
21 CFR Section Respondents per Response Responses 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.124(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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping 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., fiscal year 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.
Dated: December 9, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29672 Filed 12-15-08; 8:45 am]
BILLING CODE 4160-01-S
