Proposed Information Collection Activity; Comment Request, 27060-27061 [2011-11364]
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27060
Federal Register / Vol. 76, No. 90 / Tuesday, May 10, 2011 / Notices
to the draft recommendations. Please
limit comments to six pages.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
III. Potential Responders
HHS invites input from a broad range
of individuals and organizations that
have interests in vaccines and vaccine
safety. Some examples of these
organizations include but are not
limited to the following:
—General public;
—Advocacy groups and public interest
organizations;
—State and local governments;
—State and local public health
departments;
—Vaccine manufacturing industry,
distributors and other businesses;
—Health care professional societies and
organizations.
When responding, please self-identify
with any of the above or other categories
(include all that apply) and your name.
All comments submitted will be made
publicly available. Anonymous
submissions will not be considered and
will not have their comments posted.
Written comment submission should
not exceed six pages. Any information
you submit will be made public.
Consequently, do not send proprietary,
commercial, financial, business
confidential, trade secret, or personal
information that you do not wish to be
made public.
Public Access: Comments on the draft
report and draft recommendations will
be available to the public on the NVAC
Web site at https://www.hhs.gov/nvpo/
nvac/subgroups/vaccinesafety.html.
You may access public comments
received by going to the above Web site.
Administration for Children and
Families
Dated: May 4, 2011.
Wanda K. Jones,
Principal Deputy Assistant Secretary for
Health.
[FR Doc. 2011–11401 Filed 5–9–11; 8:45 am]
BILLING CODE 4150–44–P
Proposed Information Collection
Activity; Comment Request
Title: Request for Assistance for Child
Victims of Human Trafficking.
OMB No.: 0970–0362.
Description: The William Wilberforce
Trafficking Victims Protection
Reauthorization Act (TVPRA) of 2008,
Public Law 110–457, directs the U.S.
Secretary of Health and Human Services
(HHS), upon receipt of credible
information that a non-U.S. citizen, nonLawful Permanent Resident (alien) child
may have been subjected to a severe
form of trafficking in persons and is
seeking Federal assistance available to
victims of trafficking, to promptly
determine if the child is eligible for
interim assistance. The law further
directs the Secretary of HHS to
determine if a child receiving interim
assistance is eligible for assistance as a
victim of a severe form of trafficking in
persons after consultation with the
Attorney General, the Secretary of
Homeland Security, and
nongovernmental organizations with
expertise on victims of severe forms of
trafficking.
In developing procedures for
collecting the necessary information
from potential child victims of
trafficking, their case managers,
attorneys, or other representatives to
allow HHS to grant interim eligibility,
HHS devised a form. HHS has
determined that the use of a standard
form to collect information is the best
way to ensure requestors are notified of
their option to request assistance for
child victims of trafficking and to make
prompt and consistent determinations
about the child’s eligibility for
assistance.
Specifically, the form asks the
requestor for his/her identifying
information, for information on the
child, information describing the type of
trafficking and circumstances
surrounding the situation, and the
strengths and needs of the child. The
form also asks the requestor to verify the
information contained in the form
because the information could be the
basis for a determination of an alien
child’s eligibility for federally funded
benefits. Finally, the form takes into
consideration the need to compile
information regarding a child’s
circumstances and experiences in a nondirective, child-friendly way, and assists
the potential requestor in assessing
whether the child may have been
subjected to trafficking in persons.
The information provided through the
completion of a Request for Assistance
for Child Victims of Human Trafficking
form will enable HHS to make prompt
determinations regarding the eligibility
of an alien child for interim assistance,
inform HHS’ determination regarding
the child’s eligibility for assistance as a
victim of a severe form of trafficking in
persons, facilitate the required
consultation process, and enable HHS to
assess and address potential child
protection issues.
Respondents: Representatives of
governmental and nongovernmental
entities providing social, legal, or
protective services to alien persons
under the age of 18 (children) in the
United States who may have been
subjected to severe forms of trafficking
in persons.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Request for Assistance for Child Victims of Human Trafficking .....................
jlentini on DSKJ8SOYB1PROD with NOTICES
Instrument
200
1
1
200
Estimated Total Annual Burden
Hours: 200.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
VerDate Mar<15>2010
18:02 May 09, 2011
Jkt 223001
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
E:\FR\FM\10MYN1.SGM
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Federal Register / Vol. 76, No. 90 / Tuesday, May 10, 2011 / Notices
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
BILLING CODE 4184–01–P
Food and Drug Administration
[Docket No. FDA–2010–N–0422]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Information From United States Firms
and Processors That Export to the
European Community
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Information From United States Firms
and Processors That Export to the
European Community’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
In the
Federal Register of November 23, 2010
(75 FR 71444), the Agency announced
that the proposed information collection
had been submitted to OMB for review
and clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0320. The
approval expires on February 28, 2014.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
jlentini on DSKJ8SOYB1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
18:02 May 09, 2011
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2010–N–0631]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
[FR Doc. 2011–11360 Filed 5–9–11; 8:45 am]
Food and Drug Administration
[FR Doc. 2011–11364 Filed 5–9–11; 8:45 am]
AGENCY:
Dated: May 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
Jkt 223001
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Updating Labeling for
Susceptibility Test Information in
Systemic Antibacterial Drug Products
and Antimicrobial Susceptibility
Testing Devices
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.
SUMMARY:
Fax written comments on the
collection of information by June 9,
2011.
DATES:
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 0910–0638. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
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:
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
27061
Guidance for Industry on Updating
Labeling for Susceptibility Test
Information in Systemic Antibacterial
Drug Products and Antimicrobial
Susceptibility Testing Devices—(OMB
Control Number 0910–0638)—Extension
The Food and Drug Administration
Amendments Act of 2007 (FDAAA)
includes a requirement that FDA
identify and periodically update
susceptibility test interpretive criteria
for antibacterial drug products and
make those findings publicly available.
As a result of this provision, the
guidance explains the importance of
making available to health care
providers the most current information
regarding susceptibility test interpretive
criteria for antibacterial drug products.
To address concerns about antibacterial
drug product labeling with out-of-date
information on susceptibility test
interpretive criteria, quality control
parameters, and susceptibility test
methods, the guidance describes
procedures for FDA, applications
holders, and antimicrobial susceptibility
testing device manufacturers to ensure
that updated susceptibility test
information is available to health care
providers. Where appropriate, FDA will
identify susceptibility test interpretive
criteria, quality control parameters, and
susceptibility test methods by
recognizing annually, in a Federal
Register notice, standards developed by
one or more nationally or
internationally recognized standard
development organizations. The FDA
recognized standards will be available
to application holders of approved
antibacterial drug products for updating
their product labeling.
Application holders can use one of
the following approaches to meet their
responsibilities to update their product
labeling under the guidance and FDA
regulations: Submit a labeling
supplement that relies upon a standard
recognized by FDA in a Federal Register
notice or submit a labeling supplement
that includes data supporting a
proposed change to the microbiology
information in the labeling. In addition,
application holders should include in
their annual report an assessment of
whether the information in the
‘‘Microbiology’’ subsection of their
product labeling is current or whether
changes are needed. This information
collection is already approved by OMB
under control number 0910–0572 (the
requirement in 21 CFR 201.56(a)(2) to
update labeling when new information
becomes available that causes the
labeling to become inaccurate, false, or
misleading) and control number 0910–
0001 (the requirement in 21 CFR
E:\FR\FM\10MYN1.SGM
10MYN1
]]>Agencies
[Federal Register Volume 76, Number 90 (Tuesday, May 10, 2011)]
[Notices]
[Pages 27060-27061]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11364]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Title: Request for Assistance for Child Victims of Human
Trafficking.
OMB No.: 0970-0362.
Description: The William Wilberforce Trafficking Victims Protection
Reauthorization Act (TVPRA) of 2008, Public Law 110-457, directs the
U.S. Secretary of Health and Human Services (HHS), upon receipt of
credible information that a non-U.S. citizen, non-Lawful Permanent
Resident (alien) child may have been subjected to a severe form of
trafficking in persons and is seeking Federal assistance available to
victims of trafficking, to promptly determine if the child is eligible
for interim assistance. The law further directs the Secretary of HHS to
determine if a child receiving interim assistance is eligible for
assistance as a victim of a severe form of trafficking in persons after
consultation with the Attorney General, the Secretary of Homeland
Security, and nongovernmental organizations with expertise on victims
of severe forms of trafficking.
In developing procedures for collecting the necessary information
from potential child victims of trafficking, their case managers,
attorneys, or other representatives to allow HHS to grant interim
eligibility, HHS devised a form. HHS has determined that the use of a
standard form to collect information is the best way to ensure
requestors are notified of their option to request assistance for child
victims of trafficking and to make prompt and consistent determinations
about the child's eligibility for assistance.
Specifically, the form asks the requestor for his/her identifying
information, for information on the child, information describing the
type of trafficking and circumstances surrounding the situation, and
the strengths and needs of the child. The form also asks the requestor
to verify the information contained in the form because the information
could be the basis for a determination of an alien child's eligibility
for federally funded benefits. Finally, the form takes into
consideration the need to compile information regarding a child's
circumstances and experiences in a non-directive, child-friendly way,
and assists the potential requestor in assessing whether the child may
have been subjected to trafficking in persons.
The information provided through the completion of a Request for
Assistance for Child Victims of Human Trafficking form will enable HHS
to make prompt determinations regarding the eligibility of an alien
child for interim assistance, inform HHS' determination regarding the
child's eligibility for assistance as a victim of a severe form of
trafficking in persons, facilitate the required consultation process,
and enable HHS to assess and address potential child protection issues.
Respondents: Representatives of governmental and nongovernmental
entities providing social, legal, or protective services to alien
persons under the age of 18 (children) in the United States who may
have been subjected to severe forms of trafficking in persons.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Request for Assistance for Child Victims of 200 1 1 200
Human Trafficking..........................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 200.
In compliance with the requirements of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
by writing to the Administration for Children and Families, Office of
Administration, Office of Information Services, 370 L'Enfant Promenade,
SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail
address: infocollection@acf.hhs.gov. All requests should be identified
by the title of the information collection.
The Department specifically requests comments on: (a) Whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d)
[[Page 27061]]
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted within 60 days of this
publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011-11364 Filed 5-9-11; 8:45 am]
BILLING CODE 4184-01-P
