Agency Information Collection Activities: Submission for OMB Review; Comment Request, 9584-9585 [2011-3755]
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9584
Federal Register / Vol. 76, No. 34 / Friday, February 18, 2011 / Notices
early phase clinical studies. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirement of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information that are subject to review by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in 21 CFR
201.57 have been approved under OMB
control number 0910–0572.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances, or
https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances, or https://
www.regulations.gov.
Dated: February 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–3679 Filed 2–17–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
[Docket No. FDA–2010–N–0528]
Unapproved Animal Drugs; Extension
of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
the notice that appeared in the Federal
Register of December 20, 2010 (75 FR
79383). In the notice FDA requested
comments on strategies to address the
prevalence of animal drug products
marketed in the United States without
approval or other legal marketing status.
The Agency is taking this action in
response to requests for an extension to
allow interested persons additional time
to submit comments.
DATES: Submit electronic or written
comments by April 19, 2011.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2010–N–
0528 by any of the following methods:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier (for
paper, disk, or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the Agency name and
Docket No. FDA–2010–N–0528. All
comments received may be posted
without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Request for
Comments’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Tracey H. Forfa, Center for Veterinary
Medicine (HFV–1), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–9000,
e-mail: Tracey.Forfa@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Request for comments;
extension of comment period.
I. Background
The Food and Drug
Administration (FDA) is extending to
April 19, 2011, the comment period for
In the Federal Register of December
20, 2010 (75 FR 79383), FDA published
a notice with a 60-day comment period
ACTION:
SUMMARY:
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13:57 Feb 17, 2011
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to request comments from stakeholders
on strategies to address the prevalence
of animal drug products marketed in the
United States without approval or other
legal marketing status. The notice
expressed FDA’s interest in receiving
comments on strategies that utilize
FDA’s existing regulatory framework for
addressing this issue as well as on novel
strategies not currently employed by the
Agency.
The Agency has received requests for
a 60-day extension of the comment
period. The requests conveyed concern
that the current 60-day comment period
does not allow respondents sufficient
time to address fully the many
important issues FDA raised in the
notice.
FDA has considered the requests and
is extending the comment period for the
notice for 60 days, until April 19, 2011.
The Agency believes that a 60-day
extension allows adequate time for
interested persons to submit comments
without significantly delaying the
Agency’s consideration of these
important issues.
II. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: February 15, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2011–3712 Filed 2–17–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Correction of Burden Table.
AGENCY:
The Health Resources and
Services Administration published an
Agency Information Collection
document in the Federal Register of
SUMMARY:
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9585
Federal Register / Vol. 76, No. 34 / Friday, February 18, 2011 / Notices
January 31, 2011 (FR Doc. 2011–1997),
on page 5389, regarding the Data System
for Organ Procurement and
Transplantation Network (42 CFR Part
121, OMB No. 0915–0184): Extension.
The Burden Table is incorrect.
Correction
In the Federal Register issue of
January 31, 2011 (FR Doc. 2011–1997),
on page 5389, correct the Burden Table
as follows:
ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN
121.3(b)(2)
OPTN membership and application requirements .......
121.3
Application for Non-Institutional Members ....................
121.3(b)(4)
Appeal for OPTN membership .....................................
121.6(c) (Reporting)
Submitting criteria for organ acceptance ......................
121.6(c) (Disclosure)
Sending criteria to OPOs ..............................................
121.7(b)(4)
Reasons for Refusal .....................................................
121.7(f)
Transplant to prevent organ wastage ...........................
121.9(b)
Designated Transplant Program Requirements ...........
121.3
Personnel Change Application .....................................
121.9(d)
Appeal for designation ..................................................
Dated: February 14, 2011.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Poison Control Program
Health Resources and Services
Administration, HHS.
ACTION: Notice of Noncompetitive
Replacement Awards to the Research
Foundation of SUNY and the New York
City Health & Hospitals Corporation.
AGENCY:
HRSA will transfer funds and
duties from Kaleida Health and
University of Rochester to the Research
Foundation of SUNY d.b.a. the Upstate
New York Poison Control Center. HRSA
will also transfer funds and duties from
Winthrop University to the New York
City Health & Hospitals Corporation
d.b.a. the New York City Poison Control
Center. These transfers are necessary in
order to maintain poison control
services and education efforts
throughout the State of New York.
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Total burden
hours
120
15
1,800
20
1
20
10
200
2
1
2
3
6
900
1
900
0.5
450
900
1
900
0.5
450
900
38
34,200
0.5
17,100
260
1.5
390
0.5
195
10
1
10
5.0
50
324
1
324
10
3,240
2
1
2
6
12
954
........................
36,868
........................
23,503
Former Grantee of Record: Kaleida
Health, University of Rochester; and
Winthrop University are the three
former grantees.
Original Period of Grant Support is
from: September 1, 2009 to August 31,
2014.
Replacement awardees: The Research
Foundation of SUNY and the New York
City Health & Hospitals Corporation are
the replacement awardees.
Period of Replacement Awards: The
period of support for the replacement
awards is January 1, 2011, to August 31,
2011.
Amount of Replacement Awards is as
follows:
➢ Kaleida Health d.b.a. the Western
New York Poison Center (H4BHS15474)
will transfer $78,720 to the Research
Foundation of SUNY d.b.a. the Upstate
New York Poison Center (H4BHS15475);
➢ University of Rochester d.b.a. the
Ruth A. Lawrence Poison and Drug
Information Center (H4BHS15476) will
transfer approximately $78,820 to the
Research Foundation of SUNY d.b.a. the
Upstate New York Poison Center
(H4BHS15475); and
➢ Winthrop University d.b.a. the
Long Island Regional Poison and Drug
Information Center (H4BHS15478) will
transfer $230,397 to the New York City
Health & Hospitals Corporation d.b.a.
PO 00000
Hours per
response
3
SUPPLEMENTARY INFORMATION:
[FR Doc. 2011–3755 Filed 2–17–11; 8:45 am]
VerDate Mar<15>2010
Total
responses
40
Total .......................................................................
SUMMARY:
Responses
per
respondents
Number of
respondents
Section and activity
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the New York City Poison Control
Center (H4BHS15477).
Authority: Section 1273 of the PHS (42
U.S.C. 300d—73), as amended by Poison
Center Support Enhancement and Awareness
Act of 2008.
CFDA Number: 93.253.
Justification for the Exception to
Competition
The poison centers operated by the
Research Foundation of SUNY and the
New York City Health & Hospitals
Corporation currently provide poison
center services to the citizens of New
York, 24 hours a day, 7 days a week.
These services include telephone
treatment advice and consultation about
toxic exposures for both the public and
health care professionals and toxico and
public health surveillance. Educators at
the centers provide public education
about poison prevention and clinical
toxicology training for many different
healthcare professionals. The centers
also offer programs to help clinicians
better manage poisoning and overdose
cases that end up in a healthcare
facility.
These centers have the capacity to
provide poison control service to the
areas formerly served by Kaleida Health,
University of Rochester, and Winthrop
University, ensuring access to critical
poison emergency treatment and poison
E:\FR\FM\18FEN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 34 (Friday, February 18, 2011)]
[Notices]
[Pages 9584-9585]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-3755]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Correction of Burden Table.
-----------------------------------------------------------------------
SUMMARY: The Health Resources and Services Administration published an
Agency Information Collection document in the Federal Register of
[[Page 9585]]
January 31, 2011 (FR Doc. 2011-1997), on page 5389, regarding the Data
System for Organ Procurement and Transplantation Network (42 CFR Part
121, OMB No. 0915-0184): Extension. The Burden Table is incorrect.
Correction
In the Federal Register issue of January 31, 2011 (FR Doc. 2011-
1997), on page 5389, correct the Burden Table as follows:
Estimated Annual Reporting and Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Section and activity respondents respondents responses response hours
----------------------------------------------------------------------------------------------------------------
121.3(b)(2) ..............
OPTN membership and 40 3 120 15 1,800
application requirements...
121.3 ..............
Application for Non- 20 1 20 10 200
Institutional Members......
121.3(b)(4) ..............
Appeal for OPTN membership.. 2 1 2 3 6
121.6(c) (Reporting) ..............
Submitting criteria for 900 1 900 0.5 450
organ acceptance...........
121.6(c) (Disclosure) ..............
Sending criteria to OPOs.... 900 1 900 0.5 450
121.7(b)(4) ..............
Reasons for Refusal......... 900 38 34,200 0.5 17,100
121.7(f) ..............
Transplant to prevent organ 260 1.5 390 0.5 195
wastage....................
121.9(b) ..............
Designated Transplant 10 1 10 5.0 50
Program Requirements.......
121.3 ..............
Personnel Change Application 324 1 324 10 3,240
121.9(d) ..............
Appeal for designation...... 2 1 2 6 12
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Total................... 954 .............. 36,868 .............. 23,503
----------------------------------------------------------------------------------------------------------------
Dated: February 14, 2011.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2011-3755 Filed 2-17-11; 8:45 am]
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