Agency Information Collection Activities; Proposed Collection; Comment Request; Comment Request; Interstate Shellfish Dealer's Certificate, 68129-68130 [2012-27722]
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68129
Federal Register / Vol. 77, No. 221 / Thursday, November 15, 2012 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
New written requests to be placed on the list .....................
Biannual update ...................................................................
Occasional updates .............................................................
25
88
25
1
1
1
25
88
25
1.5
1.0
0.5
38
88
13
Total ..............................................................................
........................
........................
........................
........................
139
TKELLEY on DSK3SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of the number of firms
that will submit new written requests to
be placed on the list, biannual updates,
and occasional updates is based on
FDA’s experience maintaining the list
over the past 7 years. The estimate of
the number of hours that it will take a
firm to gather the information needed to
be placed on the list or update its
information is based on FDA’s
experience with firms submitting
similar requests. FDA believes that the
information to be submitted will be
readily available to the firms.
On average, over the last 3 years, the
list contained approximately 176 firms.
FDA estimates that, each year,
approximately 25 new firms will apply
to be added to the list. In any given year,
some firms choose not to resubmit their
information. These firms are removed
from the list quarterly. This occurrence
results in the number of firms to remain
at approximately 176. We estimate that
a firm will require 1.5 hours to read the
guidance, gather the information
needed, and to prepare a
communication to FDA that contains
the information and requests that the
firm be placed on the list for a total of
37.5 hours, rounded to 38. Under the
guidance, every 2 years each producer
on the list must provide updated
information in order to remain on the
list. FDA estimates that each year
approximately half of the firms on the
list, 88 firms (176 × 0.5 = 88), will
resubmit the information to remain on
the list. We estimate that a firm already
on the list will require 1.0 hours to
biannually update and resubmit the
information to FDA, including time
reviewing the information and
corresponding with FDA, for a total of
88 hours. In addition, FDA expects that,
each year, approximately 25 firms will
need to submit an occasional update
and each firm will require 0.5 hours to
prepare a communication to FDA
reporting the change, for a total of 12.5
hours, rounded to 13.
VerDate Mar<15>2010
16:22 Nov 14, 2012
Jkt 229001
Dated: November 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–27723 Filed 11–14–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1108]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Comment Request;
Interstate Shellfish Dealer’s Certificate
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 information collection provisions of
the Interstate Shellfish Dealer’s
Certificate.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by January 14, 2013.
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
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.
DATES:
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400T, Rockville, MD 20850,
domini.bean@fda.hhs.gov.
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.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\15NON1.SGM
15NON1
68130
Federal Register / Vol. 77, No. 221 / Thursday, November 15, 2012 / Notices
Interstate Shellfish Dealer’s Certificate
(OMB Control Number 0910–0021)—
Extension
Under 42 U.S.C. 243, FDA is required
to cooperate with and aid State and
local authorities in the enforcement of
their health regulations and is
authorized to assist States in the
prevention and suppression of
communicable diseases. Under this
authority, FDA participates with State
regulatory agencies, some foreign
nations, and the molluscan shellfish
industry in the National Shellfish
Sanitation Program (NSSP).
NSSP is a voluntary, cooperative
program to promote the safety of
molluscan shellfish by providing for the
classification and patrol of shellfish
growing waters and for the inspection
and certification of shellfish processors.
Each participating State and foreign
nation monitors its molluscan shellfish
processors and issues certificates for
those that meet the State or foreign
shellfish control authority’s criteria.
Each participating State and nation
provides a certificate of its certified
shellfish processors to FDA on Form
FDA 3038, ‘‘Interstate Shellfish Dealer’s
Certificate.’’ FDA uses this information
to publish the ‘‘Interstate Certified
Shellfish Shippers List,’’ a monthly
comprehensive listing of all molluscan
shellfish processors certified under the
cooperative program. If FDA did not
collect the information necessary to
compile this list, participating States
would not be able to identify and keep
out shellfish processed by uncertified
processors in other States and foreign
nations. Consequently, NSSP would not
be able to control the distribution of
uncertified and possibly unsafe shellfish
in interstate commerce, and its
effectiveness would be nullified.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
FDA Form
No.
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
Total hours
Submission of Interstate Shellfish Dealer’s Certificate .......................................................................
3038
40
57
2,280
0.10
228
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that 40 respondents
will submit 2,280 Interstate Shellfish
Dealer’s Certificates annually, for a total
burden of 228 hours (2,280 submissions
× 0.10 hours = 228 hours). This estimate
is based on FDA’s experience and the
number of certificates received in the
past 3 years.
Dated: November 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–27722 Filed 11–14–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1105]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Voluntary Hazard
Analysis and Critical Control Point
Manuals for Operators and Regulators
of Retail and Food Service
Establishments
AGENCY:
Food and Drug Administration,
TKELLEY on DSK3SPTVN1PROD with NOTICES
HHS.
ACTION:
Notice.
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
SUMMARY:
VerDate Mar<15>2010
16:22 Nov 14, 2012
Jkt 229001
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 information collection associated
with FDA’s technical assistance
reference manuals provided to State,
local, territorial, and tribal jurisdictions,
and other Federal Agencies to interpret
and promote the application of Hazard
Analysis and Critical Control Point
(HACCP) principles to reduce the risk of
foodborne illness in the operation of
retail and food service establishments.
DATES: Submit either electronic or
written comments on the collection of
information by January 14, 2013.
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
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:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400T, Rockville, MD 20850,
domini.bean@fda.hhs.gov.
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\15NON1.SGM
15NON1
]]>Agencies
[Federal Register Volume 77, Number 221 (Thursday, November 15, 2012)]
[Notices]
[Pages 68129-68130]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27722]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-1108]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Comment Request; Interstate Shellfish Dealer's
Certificate
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 information collection
provisions of the Interstate Shellfish Dealer's Certificate.
DATES: Submit either electronic or written comments on the collection
of information by January 14, 2013.
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 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: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T,
Rockville, MD 20850, domini.bean@fda.hhs.gov.
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.
[[Page 68130]]
Interstate Shellfish Dealer's Certificate (OMB Control Number 0910-
0021)--Extension
Under 42 U.S.C. 243, FDA is required to cooperate with and aid
State and local authorities in the enforcement of their health
regulations and is authorized to assist States in the prevention and
suppression of communicable diseases. Under this authority, FDA
participates with State regulatory agencies, some foreign nations, and
the molluscan shellfish industry in the National Shellfish Sanitation
Program (NSSP).
NSSP is a voluntary, cooperative program to promote the safety of
molluscan shellfish by providing for the classification and patrol of
shellfish growing waters and for the inspection and certification of
shellfish processors. Each participating State and foreign nation
monitors its molluscan shellfish processors and issues certificates for
those that meet the State or foreign shellfish control authority's
criteria. Each participating State and nation provides a certificate of
its certified shellfish processors to FDA on Form FDA 3038,
``Interstate Shellfish Dealer's Certificate.'' FDA uses this
information to publish the ``Interstate Certified Shellfish Shippers
List,'' a monthly comprehensive listing of all molluscan shellfish
processors certified under the cooperative program. If FDA did not
collect the information necessary to compile this list, participating
States would not be able to identify and keep out shellfish processed
by uncertified processors in other States and foreign nations.
Consequently, NSSP would not be able to control the distribution of
uncertified and possibly unsafe shellfish in interstate commerce, and
its effectiveness would be nullified.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average
Activity FDA Form No. Number of responses per Total annual burden per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of Interstate Shellfish Dealer's Certificate....... 3038 40 57 2,280 0.10 228
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that 40 respondents will submit 2,280 Interstate
Shellfish Dealer's Certificates annually, for a total burden of 228
hours (2,280 submissions x 0.10 hours = 228 hours). This estimate is
based on FDA's experience and the number of certificates received in
the past 3 years.
Dated: November 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27722 Filed 11-14-12; 8:45 am]
BILLING CODE 4160-01-P
