Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Implementation of the Food and Drug Administration Amendments Act of 2007, 38302 [2012-15718]
Download as PDF
<![CDATA[
38302
Federal Register / Vol. 77, No. 124 / Wednesday, June 27, 2012 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Form No.
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
........................................................................
........................
........................
........................
........................
21 CFR
Section
Total ..
1 There
Total hours
607
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
1210.15 ................................................................................
2
1
2
0.05
0.10
srobinson on DSK4SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated number of respondents
and hours per response are based on
FDA’s experience with the import milk
permit program and the average number
of import milk permit holders over the
past 3 years. FDA estimates that 2
respondents will submit approximately
200 Form FDA 1996 reports annually,
for a total of 600 responses. FDA
estimates the reporting burden to be 1.5
hours per response, for a total burden of
607 hours.
The Secretary of Health and Human
Services has the discretion to allow
Form FDA 1815, a duly certified
statement signed by an accredited
official of a foreign government, to be
submitted in lieu of Forms FDA 1994
and 1995. To date, Form FDA 1815 has
been submitted in lieu of these forms.
Because FDA has not received any
Forms FDA 1994 and 1995 in the last 3
years, the Agency estimates no more
than one will be submitted annually.
FDA estimates the reporting burden for
each to be 0.5 hours per response for a
total burden reporting burden of 0.5
hours each.
FDA estimates that two respondents
will submit one Form FDA 1997 report
annually, for a total of two responses.
FDA estimates the reporting burden to
be 2.0 hours per response, for a total
burden of 4 hours. FDA estimates that
two respondents will submit one Form
FDA 1993 report annually, for a total of
two responses. FDA estimates the
reporting burden to be 0.5 hours per
response, for a total burden of 1 hour.
FDA estimates that two respondents
will submit one Form FDA 1815 report
annually, for a total of two responses.
FDA estimates the reporting burden to
be 0.5 hours per response, for a total
burden of 1 hour.
With regard to records maintenance,
FDA estimates that approximately two
recordkeepers will spend 0.05 hours
annually maintaining the additional
VerDate Mar<15>2010
19:05 Jun 26, 2012
Jkt 226001
pasteurization records required by
§ 1210.15, for a total of 0.10 hours
annually.
No burden has been estimated for the
tagging requirement in § 1210.22
because the information on the tag is
either supplied by FDA (permit number)
or is disclosed to third parties as a usual
and customary part of the shipper’s
normal business activities (type of
product, shipper’s name and address).
Under 5 CFR 1320.3(c)(2), the public
disclosure of information originally
supplied by the Federal Government to
the recipient for the purpose of
disclosure to the public is not a
collection of information. Under 5 CFR
1320.3(b)(2)), the time, effort, and
financial resources necessary to comply
with a collection of information are
excluded from the burden estimate if
the reporting, recordkeeping, or
disclosure activities needed to comply
are usual and customary because they
would occur in the normal course of
business activities.
Dated: June 22, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–15719 Filed 6–26–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0755]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Implementation of the Food and Drug
Administration Amendments Act of
2007
AGENCY:
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Implementation of the Food and Drug
Administration Amendments Act of
2007’’ has been approved by the Office
of Management and Budget (OMB)
under the Paperwork Reduction Act of
1995.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
On
January 18, 2012, the Agency submitted
a proposed collection of information
entitled ‘‘Implementation of the Food
and Drug Administration Amendments
Act of 2007’’ 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 0910–0625. The
approval expires on June 30, 2015. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: June 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–15718 Filed 6–26–12; 8:45 am]
BILLING CODE 4160–01–P
Food and Drug Administration,
HHS.
PO 00000
Frm 00036
Fmt 4703
Sfmt 9990
E:\FR\FM\27JNN1.SGM
27JNN1
]]>Agencies
[Federal Register Volume 77, Number 124 (Wednesday, June 27, 2012)]
[Notices]
[Page 38302]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-15718]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0755]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Implementation of the Food and Drug
Administration Amendments Act of 2007
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Implementation of the Food and
Drug Administration Amendments Act of 2007'' has been approved by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On January 18, 2012, the Agency submitted a
proposed collection of information entitled ``Implementation of the
Food and Drug Administration Amendments Act of 2007'' 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 0910-0625. The approval expires on June 30, 2015. A copy
of the supporting statement for this information collection is
available on the Internet at https://www.reginfo.gov/public/do/PRAMain.
Dated: June 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-15718 Filed 6-26-12; 8:45 am]
BILLING CODE 4160-01-P
