Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; User Fee Cover Sheet; Form FDA 3397, 7044 [E7-2469]
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7044
Federal Register / Vol. 72, No. 30 / Wednesday, February 14, 2007 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Responses
Total Hours
Total Operating &
Maintenance
Costs
42 CFR 493.17
60
15
900
1 hr
900 hr
$45,000
Total
60
15
900
1 hr
900 hr
$45,000
1 There
are no capital costs associated with this collection of information.
The number of respondents is
approximately 60. On average, each
respondent will request categorizations
(independent of a 510(k) or PMA) 15
times per year. The cost, not including
personnel, is estimated at $50.
Thisincludes the cost of copying and
mailing copies of package inserts and a
cover letter, which includes a statement
of the reason for the request and
reference to the original 510(k) numbers,
including regulation numbers and
product codes.
Dated: February 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–2468 Filed 2–13–07; 8:45 am]
Dated: February 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–2469 Filed 2–13–07; 8:45 am]
BILLING CODE 4160–01–S
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0203]
Food and Drug Administration
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
User Fee Cover Sheet; Form FDA 3397
AGENCY:
Food and Drug Administration,
HHS.
ycherry on PROD1PC64 with PRELIMS
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘User Fee Cover Sheet; Form FDA
3397’’ has been approved by the Office
of Management and Budget (OMB)
under the Paperwork Reduction Act of
1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
SUPPLEMENTARY INFORMATION: In the
Federal Register of August 29, 2006 (71
FR 51195), the agency announced that
VerDate Aug<31>2005
17:27 Feb 13, 2007
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 0910–0297. The
approval expires on January 31, 2010. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
Jkt 211001
[Docket No. 2006N–0432]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on How to Use E-mail to
Submit Information to the Center for
Veterinary Medicine
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 March 16,
2007.
ADDRESSES: To ensure that comments on
the information collection are received,
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance:
SUPPLEMENTARY INFORMATION:
Guidance for Industry on How to Use
E-mail to Submit Information to the
Center for Veterinary Medicine—21
CFR 11.2 (OMB Control Number 0910–
0454)—Extension
The Center for Veterinary Medicine
(CVM) accepts certain types of
submissions electronically with no
requirement for a paper copy. These
types of documents are listed in public
docket 1992S–0251 as required by 21
CFR 11.2. CVM’s ability to receive and
process information submitted
electronically is limited by its current
information technology capabilities and
the requirements of the Electronic
Records; Electronic Signatures final
regulation. CVM’s guidance entitled
‘‘Guidance for Industry #108: How to
Submit Information in Electronic
Format by E-Mail’’ outlines general
standards to be used for the submission
of any information by e-mail.
In the Federal Register of November
8, 2006 (71 FR 65533), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
The likely respondents for this
collection of information are sponsors
for new animal drug applications.
FDA estimates the burden for this
collection of information as follows:
E:\FR\FM\14FEN1.SGM
14FEN1
]]>Agencies
[Federal Register Volume 72, Number 30 (Wednesday, February 14, 2007)]
[Notices]
[Page 7044]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-2469]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0203]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; User Fee Cover Sheet; Form FDA 3397
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``User Fee Cover Sheet; Form FDA
3397'' has been approved by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: In the Federal Register of August 29, 2006
(71 FR 51195), 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 0910-0297.
The approval expires on January 31, 2010. A copy of the supporting
statement for this information collection is available on the Internet
at https://www.fda.gov/ohrms/dockets.
Dated: February 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-2469 Filed 2-13-07; 8:45 am]
BILLING CODE 4160-01-S
