Proposed Information Collection Activity; Comment Request, 53906-53907 [2011-22078]
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Federal Register / Vol. 76, No. 168 / Tuesday, August 30, 2011 / Notices
continuous periods include months in
more than one taxable year pursuant to
the last paragraph of 26 U.S.C.
5000A(e)(4).
This delegation of authorities
supersedes the authorities delegated
under Title XXVII of the Public Health
Service Act that were published in the
Federal Register notice on June 23, 1998
(63 FR 34190).
This delegation of authorities is
effective immediately.
These authorities may be re-delegated.
These authorities shall be exercised
under the Department’s policy on
regulations and the existing delegation
of authority to approve and issue
regulations.
I hereby affirm and ratify any actions
taken by the Administrator, CMS, or his
or her subordinates, which involved the
exercise of the authorities under Titles
I, II, and X of the Affordable Care Act,
including Title XXVII of the Public
Health Service Act delegated herein
prior to the effective date of this
delegation of authorities.
Authority: 44 U.S.C. 3101.
Dated: August 2, 2011.
Kathleen Sebelius,
Secretary.
[FR Doc. 2011–22042 Filed 8–29–11; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry
[ATSDR–270]
Availability of Final Toxicological
Profile for RDX
Agency for Toxic Substances
and Disease Registry (ATSDR),
AGENCY:
Department of Health and Human
Services (HHS).
ACTION: Notice of availability.
This notice announces the
availability of one toxicological profile,
prepared by ATSDR for the Department
of Defense, on Royal Demolition
eXplosive (RDX), chemical name
hexahydro-1,3,5-trinitro-1,3,5-triazine,
also known as cyclonite.
FOR FURTHER INFORMATION CONTACT: Ms.
Delores Grant, Division of Toxicology
and Environmental Medicine, Agency
for Toxic Substances and Disease
Registry, Mailstop F–62, 1600 Clifton
Road, NE., Atlanta, Georgia 30333,
telephone (770) 488–3351.
SUPPLEMENTARY INFORMATION: The
Superfund Amendments and
Reauthorization Act (SARA) of 1986
(Pub. L. 99–499) amended the
Comprehensive Environmental
Response, Compensation, and Liability
Act (CERCLA or Superfund). Section
211 of SARA also amended Title 10 of
the U.S. Code, creating the Defense
Environmental Restoration Program.
Section 2704 of Title 10 of the U.S. Code
directs the Secretary of Defense to notify
the Secretary of Health and Human
Services (HHS) of not less than 25 of the
most commonly found unregulated
hazardous substances at defense
facilities. The Secretary of HHS is to
prepare toxicological profiles of these
substances. Each profile is to include an
examination, summary and
interpretation of available toxicological
information and epidemiologic
evaluations. This information is used to
ascertain the level of significant human
exposure for the substance and the
associated health effects. The
toxicological profile includes a
determination of whether adequate
information on the health effects of each
SUMMARY:
substance is available or in the process
of development. When adequate
information is not available, ATSDR, in
cooperation with the National
Toxicology Program (NTP), may plan a
program of research designed to
determine these health effects.
Notice of the availability of the draft
profile for public review and comment
was published in the Federal Register
on August 26, 2010, (75 FR 52535), with
notice of a 90-day public comment
period starting from the actual release
date. Following the close of the
comment period, chemical-specific
comments were addressed, and, where
appropriate, changes were incorporated
into each profile. The public comments
and other data submitted in response to
the Federal Register notice bears the
docket control number ATSDR–266.
This material is available for public
inspection at the Agency for Toxic
Substances and Disease Registry, 4700
Buford Highway, Building 106, Second
Floor, Chamblee, Georgia 30341
between 8 a.m. and 4:30 p.m., Monday
through Friday, except legal holidays.
Availability
This notice announces the availability
of one updated final toxicological
profile, RDX, prepared by ATSDR for
the Department of Defense. Electronic
access to this document is available at
the ATSDR Web site: https://
www.atsdr.cdc.gov/toxprofiles/
index.asp.
A printed copy of this toxicological
profile is available through the U.S.
Department of Commerce, National
Technical Information Service (NTIS),
5285 Port Royal Road, Springfield,
Virginia 22161, telephone 1–800–553–
6847. There is a charge for this profile
as determined by NTIS.
NTIS Order
No.
Hazardous substance
RDX .........................................................................................................................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Dated: August 24, 2011.
Ken Rose,
Director, Office of Policy, Planning and
Evaluation, National Center for
Environmental Health/Agency for Toxic
Substances and Disease Registry.
[FR Doc. 2011–22080 Filed 8–29–11; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
BILLING CODE 4163–70–P
Title: ORR State Plan for Grants to
States for Refugee Resettlement.
OMB No. 0970–0351.
Description: A State Plan is required
by 8 U.S.C. 1522 of the Immigration and
Nationality Act (the Act) [Title IV, Sec.
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CAS Number
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412 of the Act] for each State agency
requesting Federal funding for refugee
resettlement under 8 U.S.C. 524 [Title
IV, Sec. 414 of the Act], including
Refugee Cash and Medical Assistance,
Refugee Social Services, and Targeted
Assistance program funding. The State
Plan is a comprehensive narrative
description of the nature and scope of
a States programs and provides
assurances that the programs will be
administered in conformity with the
specific requirements stipulated in 45
CFR 400.4–400.9. The State Plan must
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53907
Federal Register / Vol. 76, No. 168 / Tuesday, August 30, 2011 / Notices
include all applicable State procedures,
designations, and certifications for each
requirement as well as supporting
documentation. A State may use a preprint format prepared by the Office of
Refugee Resettlement (ORR) of the
Administration for Children and
Families (ACF) or a different format, on
the condition that the format used meets
all of the State plan requirements under
Title IV of the Act and ORR regulations
at 45 CFR part 400.
There is no schedule for submission
of this State Plan, as all States are
currently operating under an approved
plan and are in compliance with
regulations at 45 CFR 400.4 400.9. Per
45 CFR 400.4(b), States need only certify
that the approved plan is current and
continues in effect, no later than 30 days
after the beginning of the Federal fiscal
year. Consistent with regulations, if
States wish to revise or amend the plan,
a revised plan or plan amendment must
be submitted to ORR as described at 45
CFR 400.7 400.9.
Respondents:
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses
per
respondent
Average
burden hours
per response
Total burden
hours
Title IV State Plan ............................................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Instrument
50
1
15
750
Estimated Total Annual Burden
Hours: 750.
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)
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. 2011–22078 Filed 8–29–11; 8:45 am]
BILLING CODE 4184–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–P–0460]
Determination That TALWIN
COMPOUND (Aspirin; Pentazocine
Hydrochloride) Tablets, 325 Milligrams;
Equivalent to 12.5 Milligram Base,
Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that TALWIN COMPOUND (aspirin;
pentazocine hydrochloride (HCl))
tablets, 325 milligrams (mg); equivalent
to (EQ) 12.5 mg base, were not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for aspirin;
pentazocine HCl tablets, 325 mg; EQ
12.5 mg base, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Nam
Kim, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6320, Silver Spring,
MD 20993–0002, 301–796–3601.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
SUMMARY:
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dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA). The only clinical data required
in an ANDA are data to show that the
drug that is the subject of the ANDA is
bioequivalent to the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products with
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
TALWIN COMPOUND (aspirin;
pentazocine HCl) tablets, 325 mg; EQ
12.5 mg base, are the subject of NDA
016891, held by Sanofi-aventis U.S., and
initially approved on November 12,
1975. TALWIN COMPOUND tablets are
indicated for the relief of moderate pain.
TALWIN COMPOUND (aspirin;
pentazocine HCl) tablets, 325 mg; EQ
12.5 mg base, are currently listed in the
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]]>Agencies
[Federal Register Volume 76, Number 168 (Tuesday, August 30, 2011)]
[Notices]
[Pages 53906-53907]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22078]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Title: ORR State Plan for Grants to States for Refugee
Resettlement.
OMB No. 0970-0351.
Description: A State Plan is required by 8 U.S.C. 1522 of the
Immigration and Nationality Act (the Act) [Title IV, Sec. 412 of the
Act] for each State agency requesting Federal funding for refugee
resettlement under 8 U.S.C. 524 [Title IV, Sec. 414 of the Act],
including Refugee Cash and Medical Assistance, Refugee Social Services,
and Targeted Assistance program funding. The State Plan is a
comprehensive narrative description of the nature and scope of a States
programs and provides assurances that the programs will be administered
in conformity with the specific requirements stipulated in 45 CFR
400.4-400.9. The State Plan must
[[Page 53907]]
include all applicable State procedures, designations, and
certifications for each requirement as well as supporting
documentation. A State may use a pre-print format prepared by the
Office of Refugee Resettlement (ORR) of the Administration for Children
and Families (ACF) or a different format, on the condition that the
format used meets all of the State plan requirements under Title IV of
the Act and ORR regulations at 45 CFR part 400.
There is no schedule for submission of this State Plan, as all
States are currently operating under an approved plan and are in
compliance with regulations at 45 CFR 400.4 400.9. Per 45 CFR 400.4(b),
States need only certify that the approved plan is current and
continues in effect, no later than 30 days after the beginning of the
Federal fiscal year. Consistent with regulations, if States wish to
revise or amend the plan, a revised plan or plan amendment must be
submitted to ORR as described at 45 CFR 400.7 400.9.
Respondents:
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Title IV State Plan......................... 50 1 15 750
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 750.
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) 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. 2011-22078 Filed 8-29-11; 8:45 am]
BILLING CODE 4184-01-P
