Agency Information Collection Activities; Proposed Collection; Comment Request; Information From United States Processors That Export to the European Community, 51077-51079 [2010-20379]
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Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Notices
sroberts on DSKD5P82C1PROD with NOTICES
The following types of interventions
are not eligible for review and should
not be submitted to NREPP:
1. Stand-alone pharmacologic
treatments—The evidence base for
pharmacologic treatments is reviewed
and approved through the U.S. Food
and Drug Administration (FDA). FDAapproved pharmacotherapy
interventions (on-label use) are
considered for NREPP review only
when combined with one or more
behavioral or psychosocial treatments.
2. Stand-alone smoking prevention
and/or cessation interventions—
Interventions to prevent or reduce
tobacco use are eligible for NREPP
review only when conducted as part of
a program that also addresses the
prevention or treatment of alcohol or
other drugs of abuse.
3. To remain consistent with
SAMHSA’s mission (‘‘to reduce the
impact of substance abuse and mental
illness on American communities’’),
NREPP will not accept for review, or
otherwise include on the NREPP Web
site, any interventions that have been
developed or evaluated with funds or
other support-either partially or whollyfrom organizations whose goals or
activities are determined to be
inconsistent with SAMHSA’s mission.
4. Due to a combination of limited
resources and a large number of
previously accepted mental health
submissions, only a small number of
mental health promotion or mental
health treatment interventions will be
accepted for review by NREPP in FY
2011.
5. Because of limited resources for FY
2011, multiple submissions from the
same developer-regardless of content
area-will not be accepted.
Selection of Interventions for Review
All submissions meeting the
minimum requirements will be
considered eligible for review. In
selecting interventions for review,
SAMHSA may choose to give special
consideration to interventions that meet
one or more of the following conditions:
• The original investigator(s) or an
independent party has used the same
protocol with an identical or similar
target population, and/or has used a
slightly modified protocol based on a
slightly modified population, where
results are consistent with positive
findings from the original evaluation.
• Implementation materials (e.g.,
program manuals, training guides,
measurement instruments,
implementation fidelity guides) are
available to the public at no cost.
• The intervention targets
underserved populations (e.g., minority
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populations, elderly, young adults,
individuals who are incarcerated).
• The intervention contributes to a
content area where there are currently
limited evidence-based interventions.
Interventions that are not selected for
review may be resubmitted by the
applicant in a future open submission
period.
Instructions for Submitting an
Intervention
To submit an intervention,
individuals should send a written
statement to NREPP expressing their
interest along with documentation that
demonstrates the intervention meets the
minimum requirements as described
above. All submissions must be made
either by a principal investigator (PI)
who has conducted research on the
intervention, a a project director (PD)
who has worked with an evaluator of
the intervention, or a formally
authorized delegate of the PI or PD. For
information on where to submit
materials, please call 1–866–436–7377.
Electronic submissions are preferred,
but materials may be sent to NREPP in
hard copy via postal mail or fax. To be
eligible for consideration, submissions
must be received no later than 11:59
p.m. EST on February 1, 2011; those
received before November 1, 2010, will
be disregarded.
If an intervention is accepted, the PI
will be contacted and asked to submit
additional documentation to be used in
the review. This additional
documentation includes full-text copies
of all articles and reports that provide
evidence of significant outcomes (p ∼05)
as well as copies of selected
dissemination materials in the format
they are provided to the public (e.g.,
hard copies or electronic versions of
manuals, training presentations, tools,
quality assurance protocols; URLs for
interactive Web-based resources).
The PI is expected to serve as the
main point of contact throughout the
remainder of the review process,
including approval of the final
intervention summary that is developed
by NREPP staff once the review has
been completed.
Contact Information
Individuals who have questions about
the information contained in this notice
may write to NREPP staff at
nrepp@samhsa.hhs.gov or call 1–866–
436–7377.
[FR Doc. 2010–20016 Filed 8–17–10; 8:45 am]
BILLING CODE 4160–01–M
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51077
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0422]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Information From
United States Processors That Export
to the European Community
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
reporting requirements in implementing
the lists of U.S. firms/processors
exporting shell eggs, dairy products,
game meat, game meat products, animal
casings, gelatin, and collagen to the
European Community (the EC).
DATES: Submit either electronic or
written comments on the collection of
information by October 18, 2010.
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:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
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
SUMMARY:
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Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Notices
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.
Information From U.S. Processors That
Export to the European Community
(OMB Control Number 0910–0320)—
Extension
The EC is a group of 27 European
countries that have agreed to harmonize
their commodity requirements to
facilitate commerce among member
States. EC legislation for intra-EC trade
has been extended to trade with non-EC
countries, including the United States.
For certain food products, including
those listed in this document, EC
legislation requires assurances from the
responsible authority of the country of
origin that the processor of the food is
in compliance with applicable
regulatory requirements.
FDA requests information from
processors that export certain animalderived products (e.g., shell eggs, dairy
products, game meat, game meat
products, animal casings, and gelatin) to
the EC. FDA uses the information to
maintain lists of processors that have
demonstrated current compliance with
U.S. requirements and provides the lists
to the EC quarterly. Inclusion on the list
is voluntary. EC member countries refer
to the lists at ports of entry to verify that
products offered for importation to the
EC from the United States are from
processors that meet U.S. regulatory
requirements. Products processed by
firms not on the lists are subject to
detention and possible refusal at the
port. FDA requests the following
information from each processor seeking
to be included on the lists:
• Business name and address;
• Name and telephone number of
person designated as business contact;
• Lists of products presently being
shipped to the EC and those intended to
be shipped in the next 6 months;
• Name and address of manufacturing
plants for each product; and
• Names and affiliations of any
Federal, State, or local governmental
agencies that inspect the plant,
government-assigned plant identifier
such as plant number, and last date of
inspection.
Description of Respondents: The
respondents to this collection of
information include U.S. producers of
shell eggs, dairy products, game meat,
game meat products, animal casings,
gelatin, and collagen.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Products
Shell Eggs
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
10
1
10
0.25
3
120
1
120
0.25
30
Game Meat and Game Meat Products
5
1
5
0.25
1
Animal Casings
5
1
5
0.25
1
Gelatin
3
1
3
0.25
1
Collagen
3
1
3
0.25
1
Dairy
Total
sroberts on DSKD5P82C1PROD with NOTICES
1 There
37
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimates of the number
of respondents and total annual
responses on the submissions that the
agency has received in the past 3 years
for each product type. To calculate the
estimate for the hours per response
values, we assumed that the information
requested is readily available to the
submitter. We expect that submitter will
need to gather information from
appropriate persons in the submitter’s
company and to prepare this
information for submission. We believe
that this effort should take no longer
than 15 minutes (0.25 hour) per
response. FDA estimates that it will
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receive 1 submission from 10 shell egg
producers annually, for a total of 10
annual responses. Each submission is
estimated to take 0.25 hour per response
for a total of 2.5 hours, rounded to 3
hours. FDA estimates that it will receive
1 submission from 120 dairy product
producers annually, for a total of 120
annual responses. Each submission is
estimated to take 0.25 hour per response
for a total of 30 hours. FDA estimates
that it will receive 1 submission from 5
game meat and game meat product
producers annually, for a total of 5
annual responses. Each submission is
estimated to take 0.25 hour per response
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for a total of 1.25 hours, rounded to 1
hour. FDA estimates that it will receive
1 submission from 5 animal casings
producers annually, for a total of 5
annual responses. Each submission is
estimated to take 0.25 hour per response
for a total of 1.25 hours, rounded to 1
hour. FDA estimates that it will receive
1 submission from 3 gelatin producers
annually, for a total of 3 annual
responses. Each submission is estimated
to take 0.25 hour per response for a total
of 0.75 hour, rounded to 1 hour. FDA
estimates that it will receive 1
submission from 3 collagen producers
annually, for a total of 3 annual
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Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Notices
responses. Each submission is estimated
to take 0.25 hour per response for a total
of 0.75 hour, rounded to 1 hour.
Therefore, the proposed annual
burden for this information collection is
37 hours.
Dated: August 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–20379 Filed 8–17–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0139]
Seth M. Yoser: Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) (the Agency) is
issuing an order under the Federal
Food, Drug, and Cosmetic Act (the act)
permanently debarring Seth M. Yoser,
MD from providing services in any
capacity to a person that has an
approved or pending drug product
application. We base this order on a
finding that Dr. Yoser was convicted of
a felony under Federal law for conduct
relating to the regulation of a drug
product under the act. Dr. Yoser was
given notice of the proposed permanent
debarment and an opportunity to
request a hearing within the timeframe
prescribed by regulation. In a May 20,
2010, letter to FDA, Dr. Yoser, through
counsel, notified FDA that he
acquiesces to debarment and therefore
he has waived his right to a hearing
concerning this action.
DATES: This order is effective May 20,
2010.
ADDRESSES: Submit applications for
special termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kenny Shade, Division of Compliance
Policy (HFC–230), Office of
Enforcement, Office of Regulatory
Affairs, Food and Drug Administration,
5600 Fishers Lane, Rockville, MD
20857, 240–632–6844.
SUPPLEMENTARY INFORMATION:
sroberts on DSKD5P82C1PROD with NOTICES
SUMMARY:
I. Background
Section 306(a)(2)(B) of the act (21
U.S.C. 335a(a)(2)(B)) requires debarment
of an individual if FDA finds that the
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individual has been convicted of a
felony under Federal law for conduct
otherwise relating to the regulation of
any drug product under the act.
On February 23, 2010, the U.S.
District Court for the Western District of
Tennessee entered judgment against Dr.
Yoser for ten counts of mail fraud in
violation of 21 U.S.C. 1341, twentythree counts of unlicensed wholesale
distribution of prescription drugs in
violation of 21 U.S.C. 331(t),
333(b)(1)(D), and 353(e)(2)(A); and two
counts of wire fraud in violation of 18
U.S.C. 1343.
FDA’s finding that debarment is
appropriate is based on the felony
convictions referenced herein for
conduct relating to the regulation of a
drug product. The factual basis for those
convictions is as follows: Dr. Yoser was
employed by the Eye Specialty Group
(ESG), formerly known as the
Vitreorentinal Foundation, and he was a
partner of ESG from on or about June
2005, until approximately May 12, 2008.
During the course of his employment
and partnership with ESG, he performed
treatments which included
administering the prescription drugs
Visudyne, Lucentis, and Avastin to treat
Wet Aged Macular Degeneration.
Beginning on or about July 1, 2002,
and continuing up to and including May
12, 2008, Dr. Yoser did knowingly
devise a scheme and artifice to defraud
ESG and Medicare in order to obtain
money and property by means of false
and fraudulent representation, billing,
and pretense. As part of that scheme, he
billed Medicare for Visudyne, Avastin,
and Lucentis that he purportedly used
to treat ESG patients but that he actually
diverted from ESG patients and sold.
Beginning on or about April 14, 2004,
through on or about October 2, 2007, in
the Western District of Tennessee, and
elsewhere, Dr. Yoser did knowingly
engage in or cause the wholesale
distribution in interstate commerce of
the prescription drugs, Visudyne and
Lucentis in Louisiana, Tennessee,
Texas, and Arkansas without being
licensed by those states in violation of
21 U.S.C. 331(t), 333(b)(1)(D), and
353(e)(2)(A).
As a result of his convictions, on
April 19, 2010, FDA sent Dr. Yoser a
notice by certified mail proposing to
permanently debar him from providing
services in any capacity to a person that
has an approved or pending drug
product application. The proposal was
based on a finding, under section
306(a)(2)(B) of the act, that Dr. Yoser
was convicted of felonies under Federal
law for conduct relating to the
regulation of a drug product under the
act. The proposal also offered Dr. Yoser
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51079
an opportunity to request a hearing,
providing him 30 days from the date of
receipt of the letter in which to file the
request, and advised him that failure to
request a hearing constituted a waiver of
the opportunity for a hearing and of any
contentions concerning this action. Dr.
Yoser’s attorney filed a May 20, 2010,
response in which he stated that Dr.
Yoser did not object to debarment and
further clarified in writing that the May
20, 2010, letter intended to express Dr.
Yoser’s acquiescence to debarment. By
acquiescing to debarment, as provided
for in section 306(c)(2)(B) of the act, Dr.
Yoser waived his opportunity for a
hearing and any contentions concerning
his debarment.
II. Findings and Order
Therefore, the Director, Office of
Enforcement, Office of Regulatory
Affairs, under section 306(a)(2)(B) of the
act, under authority delegated to the
Acting Director (Staff Manual Guide
1410.35), finds that Seth M. Yoser has
been convicted of a felony under
Federal law for conduct relating to the
regulation of a drug product under the
act.
As a result of the foregoing finding
and based on his notification of
acquiescence, Dr. Yoser is permanently
debarred from providing services in any
capacity to a person with an approved
or pending drug product application
under sections 505, 512, or 802 of the
act (21 U.S.C. 355, 360b, or 382), or
under section 351 of the Public Health
Service Act (42 U.S.C. 262), effective
May 20, 2010, the date of the
notification of acquiesce (see DATES) (see
sections 306(c)(1)(B), (c)(2)(A)(ii),
(c)(2)(B), and 201(dd) of the act (21
U.S.C. 335a(c)(1)(B), (c)(2)(A)(ii),
(c)(2)(B), and 321(dd))). Any person
with an approved or pending drug
product application who knowingly
employs or retains as a consultant or
contractor, or otherwise uses the
services of Dr. Yoser, in any capacity
during Dr. Yoser’s debarment, will be
subject to civil money penalties (section
307(a)(6) of the act (21 U.S.C.
335b(a)(6))). If Dr. Yoser provides
services in any capacity to a person with
an approved or pending drug product
application during his period of
debarment he will be subject to civil
money penalties (section 307(a)(7) of the
act). In addition, FDA will not accept or
review any abbreviated new drug
applications submitted by or with the
assistance of Dr. Yoser during his period
of debarment (section 306(c)(1)(B) of the
act).
Any application by Dr. Yoser for
special termination of debarment under
section 306(d)(4) of the act should be
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]]>Agencies
[Federal Register Volume 75, Number 159 (Wednesday, August 18, 2010)]
[Notices]
[Pages 51077-51079]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-20379]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0422]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Information From United States Processors That Export
to the European Community
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 reporting requirements in
implementing the lists of U.S. firms/processors exporting shell eggs,
dairy products, game meat, game meat products, animal casings, gelatin,
and collagen to the European Community (the EC).
DATES: Submit either electronic or written comments on the collection
of information by October 18, 2010.
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: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
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
[[Page 51078]]
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.
Information From U.S. Processors That Export to the European Community
(OMB Control Number 0910-0320)--Extension
The EC is a group of 27 European countries that have agreed to
harmonize their commodity requirements to facilitate commerce among
member States. EC legislation for intra-EC trade has been extended to
trade with non-EC countries, including the United States. For certain
food products, including those listed in this document, EC legislation
requires assurances from the responsible authority of the country of
origin that the processor of the food is in compliance with applicable
regulatory requirements.
FDA requests information from processors that export certain
animal-derived products (e.g., shell eggs, dairy products, game meat,
game meat products, animal casings, and gelatin) to the EC. FDA uses
the information to maintain lists of processors that have demonstrated
current compliance with U.S. requirements and provides the lists to the
EC quarterly. Inclusion on the list is voluntary. EC member countries
refer to the lists at ports of entry to verify that products offered
for importation to the EC from the United States are from processors
that meet U.S. regulatory requirements. Products processed by firms not
on the lists are subject to detention and possible refusal at the port.
FDA requests the following information from each processor seeking to
be included on the lists:
Business name and address;
Name and telephone number of person designated as business
contact;
Lists of products presently being shipped to the EC and
those intended to be shipped in the next 6 months;
Name and address of manufacturing plants for each product;
and
Names and affiliations of any Federal, State, or local
governmental agencies that inspect the plant, government-assigned plant
identifier such as plant number, and last date of inspection.
Description of Respondents: The respondents to this collection of
information include U.S. producers of shell eggs, dairy products, game
meat, game meat products, animal casings, gelatin, and collagen.
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
Products Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Shell Eggs 10 1 10 0.25 3
----------------------------------------------------------------------------------------------------------------
Dairy 120 1 120 0.25 30
----------------------------------------------------------------------------------------------------------------
Game Meat and 5 1 5 0.25 1
Game Meat
Products
----------------------------------------------------------------------------------------------------------------
Animal Casings 5 1 5 0.25 1
----------------------------------------------------------------------------------------------------------------
Gelatin 3 1 3 0.25 1
----------------------------------------------------------------------------------------------------------------
Collagen 3 1 3 0.25 1
----------------------------------------------------------------------------------------------------------------
Total ................. ................. ................. .................. 37
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA bases its estimates of the number of respondents and total
annual responses on the submissions that the agency has received in the
past 3 years for each product type. To calculate the estimate for the
hours per response values, we assumed that the information requested is
readily available to the submitter. We expect that submitter will need
to gather information from appropriate persons in the submitter's
company and to prepare this information for submission. We believe that
this effort should take no longer than 15 minutes (0.25 hour) per
response. FDA estimates that it will receive 1 submission from 10 shell
egg producers annually, for a total of 10 annual responses. Each
submission is estimated to take 0.25 hour per response for a total of
2.5 hours, rounded to 3 hours. FDA estimates that it will receive 1
submission from 120 dairy product producers annually, for a total of
120 annual responses. Each submission is estimated to take 0.25 hour
per response for a total of 30 hours. FDA estimates that it will
receive 1 submission from 5 game meat and game meat product producers
annually, for a total of 5 annual responses. Each submission is
estimated to take 0.25 hour per response for a total of 1.25 hours,
rounded to 1 hour. FDA estimates that it will receive 1 submission from
5 animal casings producers annually, for a total of 5 annual responses.
Each submission is estimated to take 0.25 hour per response for a total
of 1.25 hours, rounded to 1 hour. FDA estimates that it will receive 1
submission from 3 gelatin producers annually, for a total of 3 annual
responses. Each submission is estimated to take 0.25 hour per response
for a total of 0.75 hour, rounded to 1 hour. FDA estimates that it will
receive 1 submission from 3 collagen producers annually, for a total of
3 annual
[[Page 51079]]
responses. Each submission is estimated to take 0.25 hour per response
for a total of 0.75 hour, rounded to 1 hour.
Therefore, the proposed annual burden for this information
collection is 37 hours.
Dated: August 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-20379 Filed 8-17-10; 8:45 am]
BILLING CODE 4160-01-S
