Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fees and Fee Waivers and Reductions, 6475-6476 [2011-2441]
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Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Notices
during the pre-, during-, and postdeployment phases will also help to
identify which responders would
benefit from medical referral and
possible enrollment in a long-term
health surveillance program.
The document, entitled ‘‘Emergency
Responder Health Monitoring and
Surveillance,’’ can be viewed at:
https://www.cdc.gov/niosh/docket/
review/docket223/.
This guidance does not have the force
and effect of the law.
Public Comment Period: Comments
must be received by April 5, 2011.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket Number NIOSH–223]
Emergency Responder Health
Monitoring and Surveillance
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Notice of draft publication
available for public comment.
AGENCY:
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Written comments may be
submitted to the NIOSH Docket Office,
identified by Docket Number NIOSH–
223, by any of the following methods:
• Mail: NIOSH Docket Office, Robert
A. Taft Laboratories, MS–C34, 4676
Columbia Parkway, Cincinnati, Ohio
45226.
• Facsimile: (513) 533–8285.
• E-mail: nioshdocket@cdc.gov.
ADDRESSES:
The National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC)
announces the availability of the
following draft publication for public
comment. The document is entitled,
‘‘Emergency Responder Health
Monitoring and Surveillance.’’
The draft document and instructions
for submitting comments can be found
at: https://www.cdc.gov/niosh/docket/
review/docket223/.
The document proposes a new
framework for ensuring responder safety
and health by monitoring and
conducting surveillance of their health
and safety during the entire cycle of
emergency response, including the predeployment, deployment, and postdeployment phases of a response. The
proposed system is referred to as the
‘‘Emergency Responder Health
Monitoring and Surveillance (ERHMS)’’
system, which includes a guidance
section describing the principles of
ensuring optimal responder safety and
health, as well as a tools section to help
facilitate the execution of these
principles during an actual response.
The goals of this proposed system are
to ensure that only properly trained and
fit responders are deployed to a
response, that the health and safety of
all responders are appropriately
monitored during a response, and that a
systematic and comprehensive
evaluation be conducted to determine
the potential need for long term
surveillance of responders’ health after
their deployment has been completed.
This system will help to ensure that
hazardous occupational exposures and
signs and symptoms observed during an
emergency response are utilized to
mitigate adverse physical and
psychological outcomes and determine
whether protective measures are
sufficient to prevent or reduce harmful
exposures to workers. Data collected
SUMMARY:
All information received in response to
this notice will be available for public
examination and copying at the NIOSH
Docket Office, 4676 Columbia Parkway,
Room 111, Cincinnati, Ohio 45226.
A complete electronic docket
containing all comments submitted will
be available on the NIOSH Web page at
https://www.cdc.gov/niosh/docket, and
comments will be available in writing
by request. NIOSH includes all
comments received without change in
the docket, including any personal
information provided. All electronic
comments should be formatted as
Microsoft Word. Please make reference
to Docket Number NIOSH–223.
FOR FURTHER INFORMATION CONTACT:
´
Renee Funk, D.V.M., telephone (404)
498–1376, e-mail rjf8@cdc.gov, NIOSH,
MS–E20, 1600 Clifton Road NE.,
Atlanta, GA 30333.
Dated: January 28, 2011.
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2011–2527 Filed 2–3–11; 8:45 am]
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6475
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0603]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Animal Drug User
Fees and Fee Waivers and Reductions
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 March 7,
2011.
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 e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0540. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Johnny Vilela, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7651, e-mail:
Juanmanuel.vilela@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.
SUMMARY:
Animal Drug User Fees and Fee
Waivers and Reductions—(OMB
Control Number 0910–0540)—Extension
Enacted on November 18, 2003, the
Animal Drug User Fee Act (ADUFA)
(Pub. L. 108–130) amended the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) and requires FDA to assess
and collect user fees for certain
applications, products, establishments,
and sponsors. It also requires the
Agency to grant a waiver from or a
reduction of those fees in certain
circumstances. Thus, to implement this
statutory provision of ADUFA, FDA
developed a guidance entitled
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04FEN1
6476
Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Notices
‘‘Guidance for Industry: Animal Drug
User Fees and Fee Waivers and
Reductions.’’ This document provides
guidance on the types of fees FDA is
authorized to collect under ADUFA, and
how to request waivers and reductions
from FDA’s animal drug user fees. The
guidance also describes the types of fees
and fee waivers and reductions, the
information FDA recommends
respondents submit in support of a
request for a fee waiver or reduction,
how respondents may submit such a
request, and FDA’s process for
reviewing requests.
Respondents to this collection of
information are new animal drug
sponsors. Requests for waivers or
reductions may be submitted by a
person paying any of the animal drug
user fees assessed—application fees,
product fees, establishment fees, or
sponsor fees.
In the Federal Register of December 2,
2010 (75 FR 75175), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
FD&C Act section
740(d)(1)(A) Significant barrier to innovation ......................
740(d)(1)(B) Fees exceed cost ............................................
740(d)(1)(C) Free choice feeds ...........................................
740(d)(1)(D) Minor use or minor species ............................
740(d)(1)(E) Small business ................................................
Request for reconsideration of a decision ...........................
Request for review—(user fee appeal officer) .....................
Annual
frequency per
response
22
0
2
52
0
5
2
Total annual
responses
1
1
1
1
1
1
1
22
0
2
52
0
5
2
Total ..............................................................................
1 There
Dated: January 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–2441 Filed 2–3–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0053]
Town Hall Discussion With the Director
of the Center for Devices and
Radiological Health and Other Senior
Center Management
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
srobinson on DSKHWCL6B1PROD with NOTICES
Total hours
2
2
2
2
0
2
2
44
0
4
104
0
10
4
166
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on FDA’s database system,
there are an estimated 250 sponsors of
products subject to ADUFA. However,
not all sponsors will have any
submissions in a given year and some
may have multiple submissions. The
total number of waiver requests is based
on the number of submission types
received by FDA in fiscal year 2008.
AGENCY:
Hours per
response
The Food and Drug Administration
(FDA) is announcing a public meeting
entitled ‘‘Town Hall Discussion with the
Director of the Center for Devices and
Radiological Health and Other Senior
Center Management.’’ The purpose of
this public meeting in the Dallas-Fort
Worth, TX area is to engage in a
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dialogue about issues of importance to
FDA’s Center for Devices and
Radiological Health (CDRH) and to
members of the public, including the
medical device industry, healthcare
professionals, patients, and consumers.
Dates and Time: The public meeting
will be held on March 10, 2011, from 8
a.m. to 12 noon CST.
Location: The public meeting will be
held at the Irving Convention Center at
Las Colinas, 500 West Las Colinas Blvd.,
Irving, TX 75039. The meeting will not
be videotaped or webcast.
Contact: Heather Howell, Food and
Drug Administration; Center for Devices
and Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, rm. 4320,
Silver Spring, MD 20993, 301–796–
5718, e-mail:
heather.howell@fda.hhs.gov.
Registration and Requests for Oral
Presentations: If you wish to attend the
public meeting, you must register online
at https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
ucm239730.htm. Persons without
Internet access may call Heather Howell
at 301–796–5718 to register for the
meeting.
Provide complete contact information
for each attendee, including name, title,
company or organization, address, email, telephone and fax number.
Registration requests must be received
by 5 p.m. EST on Friday, February 25,
2011.
If you wish to make an oral
presentation during any of the sessions
at the meeting (see section II of this
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document, Public Meeting), you must
indicate this at the time of registration.
FDA will do its best to accommodate
requests to speak. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
presentations, and to request time for a
joint presentation. FDA will determine
the amount of time allotted to each
presenter and the approximate time that
each oral presentation is scheduled to
begin.
Registration is free and will be on a
first-come, first-served basis. Early
registration is recommended because
seating is limited. FDA may limit the
number of participants from each
organization based on space limitations.
Registrants will receive confirmation
once they have been accepted. Onsite
registration the day of the public
meeting will be provided on a spaceavailable basis beginning at 7 a.m. CST.
If you need special accommodations
due to a disability, please contact Susan
Monahan at 301–796–5661, or by e-mail
at susan.monahan@fda.hhs.gov at least
7 days in advance of the meeting.
Comments: FDA is holding this public
meeting to share information and
discuss issues of importance to the
public, including the medical device
industry, healthcare professionals,
patients, and consumers.
Regardless of attendance at the public
meeting, interested persons may submit
either electronic or written comments.
Submit electronic comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
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]]>Agencies
[Federal Register Volume 76, Number 24 (Friday, February 4, 2011)]
[Notices]
[Pages 6475-6476]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2441]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0603]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Animal Drug User Fees
and Fee Waivers and Reductions
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 March
7, 2011.
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 e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0540.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Johnny Vilela, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-7651, e-mail:
Juanmanuel.vilela@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.
Animal Drug User Fees and Fee Waivers and Reductions--(OMB Control
Number 0910-0540)--Extension
Enacted on November 18, 2003, the Animal Drug User Fee Act (ADUFA)
(Pub. L. 108-130) amended the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) and requires FDA to assess and collect user fees for certain
applications, products, establishments, and sponsors. It also requires
the Agency to grant a waiver from or a reduction of those fees in
certain circumstances. Thus, to implement this statutory provision of
ADUFA, FDA developed a guidance entitled
[[Page 6476]]
``Guidance for Industry: Animal Drug User Fees and Fee Waivers and
Reductions.'' This document provides guidance on the types of fees FDA
is authorized to collect under ADUFA, and how to request waivers and
reductions from FDA's animal drug user fees. The guidance also
describes the types of fees and fee waivers and reductions, the
information FDA recommends respondents submit in support of a request
for a fee waiver or reduction, how respondents may submit such a
request, and FDA's process for reviewing requests.
Respondents to this collection of information are new animal drug
sponsors. Requests for waivers or reductions may be submitted by a
person paying any of the animal drug user fees assessed--application
fees, product fees, establishment fees, or sponsor fees.
In the Federal Register of December 2, 2010 (75 FR 75175), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
FD&C Act section Number of frequency per Total annual Hours per Total hours
respondents response responses response
----------------------------------------------------------------------------------------------------------------
740(d)(1)(A) Significant barrier 22 1 22 2 44
to innovation..................
740(d)(1)(B) Fees exceed cost... 0 1 0 2 0
740(d)(1)(C) Free choice feeds.. 2 1 2 2 4
740(d)(1)(D) Minor use or minor 52 1 52 2 104
species........................
740(d)(1)(E) Small business..... 0 1 0 0 0
Request for reconsideration of a 5 1 5 2 10
decision.......................
Request for review--(user fee 2 1 2 2 4
appeal officer)................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 166
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on FDA's database system, there are an estimated 250 sponsors
of products subject to ADUFA. However, not all sponsors will have any
submissions in a given year and some may have multiple submissions. The
total number of waiver requests is based on the number of submission
types received by FDA in fiscal year 2008.
Dated: January 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-2441 Filed 2-3-11; 8:45 am]
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