Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Application for Food and Drug Administration Approval to Market a New Drug, 35099 [05-11862]
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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]
[Page 35099]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-11862]
-----------------------------------------------------------------------
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
AGENCY: Food and Drug Administration, HHS.
ACTION: 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 Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1482.
SUPPLEMENTARY INFORMATION: 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.
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
