Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Prohibited From Use in Animal Food or Feed, 12486-12487 [2015-05356]
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Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices
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privacy-policy.
comments should be identified with the
OMB control number 0910–0627. Also
include the FDA docket number found
in brackets in the heading of this
document.
15. Contact Us
Please visit the Contest Web site for
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FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd.; COLE–14526, Silver
Spring, MD 20993–0002 PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Jessica Rich,
Director, Bureau of Consumer Protection.
[FR Doc. 2015–05442 Filed 3–6–15; 8:45 am]
BILLING CODE 6750–01–P
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:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Substances Prohibited From Use in
Animal Food or Feed—21 CFR Part 589
(OMB Control Number 0910–0627—
Revision)
[Docket No. FDA–2011–N–0510]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Substances
Prohibited From Use in Animal Food or
Feed
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 April 8,
2015.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
SUMMARY:
This regulation prohibits the use of
certain cattle origin materials in the
food or feed of all animals to help
prevent the spread of bovine spongiform
encephalopathy (BSE) in U.S. cattle.
BSE is a progressive and fatal
neurological disorder of cattle that
results from an unconventional
transmissible agent. BSE belongs to the
family of diseases known as
transmissible spongiform
encephalopathies (TSEs). All TSEs
affect the central nervous system of
infected animals. These measures will
further strengthen existing safeguards
against BSE.
In the Federal Register of November
21, 2014 (79 FR 69493), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. One comment was received
however it did not respond to any of the
four information collection topics
solicited and is therefore not addressed
by the Agency.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR Section 589.2001;
Substances prohibited from use in
animal food or feed
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeper
Total hours
Operating and
maintenance
costs
175
50
175
1
1
1
175
50
175
20
20
26
3,500
1,000
4,550
$59,500
17,000
80,580
Total ..................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
589.2001(c)(2)(vi) and (c)(3)(i) ................
589.2001(c)(2)(ii) ......................................
589.2001(c)(3)(i)(A) ..................................
........................
........................
........................
........................
9,050
157,080
1 There
are no capital costs associated with this collection of information.
Description of Respondents for
Recordkeeping: Rendering facilities,
medicated feed manufacturers, livestock
feeders.
VerDate Sep<11>2014
18:04 Mar 06, 2015
Jkt 235001
The Agency’s recordkeeping burden
estimate was calculated by multiplying
the number of recordkeepers times the
number of records per recordkeeper to
determine the total annual number of
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
records. The total number of annual
records were then multiplied by the
average burden per recordkeeper to
determine the total number of burden
hours.
E:\FR\FM\09MRN1.SGM
09MRN1
12487
Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
One-time (initial) burden ......................................................
Burden from future review ...................................................
1 There
1
1
Average
burden per
respondent
Total annual
responses
1
1
1
1
Total hours
80
26
80
26
are no capital costs or operating costs associated with the collection of information.
Description of Respondents for
Reporting: The final regulation on BSE
(73 FR 22720) included a provision that
exempts cattle materials prohibited in
animal feed (CMPAF) from designated
countries from the prohibition on its use
in animal feed. A foreign country
seeking this designation will submit a
written request to FDA that includes a
variety of information about the
country’s BSE status (§ 589.2001(f)).
During the past 6 years, FDA received
2 requests from countries to be
exempted from CMPAF restrictions.
One-Time (Initial) Reporting Burden
There is a one-time burden to
countries that apply to FDA seeking to
be designated as not subject to
restrictions applicable to CMPAF. We
estimate that each country that applies
for an exclusion will spend 80 hours
putting information together to submit
to FDA. Table 2 row 1 presents the onetime burden for the exclusion. (See final
BSE regulation at 73 FR 22754).
Recurring Burden
Countries that successfully petition
FDA to be designated as exempt from
certain BSE-related restrictions
applicable to animal feed will be subject
to future review by FDA to ensure that
their designation remains appropriate.
As part of this process, FDA may ask
designated countries from time-to-time
to confirm that their BSE situation and
the information submitted by them in
support of their original application
remains unchanged. We assume it will
take FDA and the designated country
undergoing a review in the future about
one third the time and effort it did when
the information was submitted. Table 2
row 2 presents the expected recurring
burden.
mstockstill on DSK4VPTVN1PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
21 CFR section 589.2001(f)
Dated: March 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–05356 Filed 3–6–15; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
18:04 Mar 06, 2015
Jkt 235001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Sciences; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Center for
Advancing Translational Sciences Special
Emphasis Panel Small Business Innovation
Research (SBIR).
Date: March 31, 2015.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Suites, 6711
Democracy Boulevard, Bethesda, MD 20817.
Contact Person: Rahat Khan, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Center for Advancing
Translational Sciences, 6701 Democracy
Blvd., Rm 1078, Bethesda, MD 20892, 301–
894–7319, khanr2@csr.nih.gov.
Name of Committee: National Center for
Advancing Translational Sciences Special
Emphasis Panel CTSA Meeting 1.
Date: April 8–9, 2015.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Washington/Rockville 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: Carol Lambert, Ph.D.,
Acting Deputy Director, Office of Grants
Management & Scientific Review, National
Center for Advancing Translational Sciences
(NCATS) National Institutes of Health, 6701
Democracy Boulevard, Democracy 1, Room
1076, Bethesda, MD 20892, 301–435–0814,
lambert@mail.nih.gov.
Name of Committee: National Center for
Advancing Translational Sciences Special
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
Emphasis Panel 2015 CTSA Application
Review.
Date: April 15–16, 2015.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Washington/Rockville 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: Guo He Zhang, Ph.D.,
MPH, Scientific Review Office, Office of
Grants Management & Scientific Review,
National Center for Advancing Translational
Sciences (NCATS) National Institutes of
Health, 6701 Democracy Boulevard,
Democracy 1, Room 1064, Bethesda, MD
20892, 301–435–0812, zhanggu@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.350, B–Cooperative Agreements;
93.859, Biomedical Research and Research
Training, National Institutes of Health, HHS).
Dated: March 3, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–05304 Filed 3–6–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request Surveys and
Interviews To Support an Evaluation of
the Innovative Molecular Analysis
Technologies (IMAT) Program (NCI)
Under the provisions of
section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH), has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on December 4,
2014, Vol. 79, Page 72004 and allowed
60-days for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Cancer Institute (NCI),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
SUMMARY:
E:\FR\FM\09MRN1.SGM
09MRN1
]]>Agencies
[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)]
[Notices]
[Pages 12486-12487]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05356]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0510]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Substances Prohibited
From Use in Animal Food or Feed
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 April
8, 2015.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0627.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd.; COLE-14526, Silver
Spring, MD 20993-0002 PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Substances Prohibited From Use in Animal Food or Feed--21 CFR Part 589
(OMB Control Number 0910-0627--Revision)
This regulation prohibits the use of certain cattle origin
materials in the food or feed of all animals to help prevent the spread
of bovine spongiform encephalopathy (BSE) in U.S. cattle. BSE is a
progressive and fatal neurological disorder of cattle that results from
an unconventional transmissible agent. BSE belongs to the family of
diseases known as transmissible spongiform encephalopathies (TSEs). All
TSEs affect the central nervous system of infected animals. These
measures will further strengthen existing safeguards against BSE.
In the Federal Register of November 21, 2014 (79 FR 69493), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received however it did not
respond to any of the four information collection topics solicited and
is therefore not addressed by the Agency.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average Operating and
21 CFR Section 589.2001; Substances prohibited from use Number of records per Total annual burden per Total hours maintenance
in animal food or feed recordkeepers recordkeeper records recordkeeper costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
589.2001(c)(2)(vi) and (c)(3)(i)........................ 175 1 175 20 3,500 $59,500
589.2001(c)(2)(ii)...................................... 50 1 50 20 1,000 17,000
589.2001(c)(3)(i)(A).................................... 175 1 175 26 4,550 80,580
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. .............. 9,050 157,080
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.
Description of Respondents for Recordkeeping: Rendering facilities,
medicated feed manufacturers, livestock feeders.
The Agency's recordkeeping burden estimate was calculated by
multiplying the number of recordkeepers times the number of records per
recordkeeper to determine the total annual number of records. The total
number of annual records were then multiplied by the average burden per
recordkeeper to determine the total number of burden hours.
[[Page 12487]]
Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section 589.2001(f) Number of responses per Total annual Average burden Total hours
respondents respondent responses per respondent
----------------------------------------------------------------------------------------------------------------
One-time (initial) burden....... 1 1 1 80 80
Burden from future review....... 1 1 1 26 26
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating costs associated with the collection of information.
Description of Respondents for Reporting: The final regulation on
BSE (73 FR 22720) included a provision that exempts cattle materials
prohibited in animal feed (CMPAF) from designated countries from the
prohibition on its use in animal feed. A foreign country seeking this
designation will submit a written request to FDA that includes a
variety of information about the country's BSE status (Sec.
589.2001(f)). During the past 6 years, FDA received 2 requests from
countries to be exempted from CMPAF restrictions.
One-Time (Initial) Reporting Burden
There is a one-time burden to countries that apply to FDA seeking
to be designated as not subject to restrictions applicable to CMPAF. We
estimate that each country that applies for an exclusion will spend 80
hours putting information together to submit to FDA. Table 2 row 1
presents the one-time burden for the exclusion. (See final BSE
regulation at 73 FR 22754).
Recurring Burden
Countries that successfully petition FDA to be designated as exempt
from certain BSE-related restrictions applicable to animal feed will be
subject to future review by FDA to ensure that their designation
remains appropriate. As part of this process, FDA may ask designated
countries from time-to-time to confirm that their BSE situation and the
information submitted by them in support of their original application
remains unchanged. We assume it will take FDA and the designated
country undergoing a review in the future about one third the time and
effort it did when the information was submitted. Table 2 row 2
presents the expected recurring burden.
Dated: March 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05356 Filed 3-6-15; 8:45 am]
BILLING CODE 4164-01-P
