Agency Information Collection Activities: Submission for OMB Review; Comment Request, 37813-37814 [2011-16233]
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Federal Register / Vol. 76, No. 124 / Tuesday, June 28, 2011 / Notices
Information provides funding to EPA’s
Exchange Network partners (states,
territories, and Federally recognized
Indian Tribes) to support the
development of the NEIEN. The NEIEN
is an Internet and- standards-based,
secure information system that supports
the electronic collection, exchange, and
integration of data among its partners.
Funding for the Grant Program has been
provided through annual congressional
appropriations for the EPA.
To enhance the quality and overall
public benefit of the Network, EPA
proposes to collect information from the
NEIEN grantees about how they intend
to ensure quality in their projects and
the environmental outcomes and
outputs from their projects. The
proposed Quality Assurance Reporting
Form is intended to provide a simple
means for grant recipients to describe
how quality will be addressed
throughout their projects. The Quality
Assurance Reporting Form is derived
from guidelines provided in the NEIEN
2006 grant solicitation notice. As a
stipulation of their award, grant
recipients are to submit the form within
ninety days of grant award.
Grantees are currently required to
submit semi-annual progress reports as
a stipulation of their award. In these
reports, grantees outline project goals,
activities required to meet these goals,
and outputs and outcomes of activities
to date. At the request of numerous
grantees, we are proposing to offer the
Progress Reporting Form as a vehicle for
collecting information. This form is
easier to complete than an unstructured
narrative; it can be used as the semiannual and final report form and the
information returned will be of higher
quality and comparable.
Burden Statement: The annual public
reporting and recordkeeping burden for
this collection of information is
estimated to average 1.5 hours for the
Semi-Annual Report Form per response
and 1 hour per Quality Assurance Form
per response. Burden means the total
time, effort, or financial resources
expended by persons to generate,
maintain, retain, or disclose or provide
information to or for a Federal agency.
This includes the time needed to review
instructions; develop, acquire, install,
and utilize technology and systems for
the purposes of collecting, validating,
and verifying information, processing
and maintaining information, and
disclosing and providing information;
adjust the existing ways to comply with
any previously applicable instructions
and requirements that have
subsequently changed; train personnel
to be able to respond to a collection of
information; search data sources;
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complete and review the collection of
information; and transmit or otherwise
disclose the information.
Respondents/Affected Entities: State,
Tribal, and Territorial Environmental
Offices receiving NEIEN grants.
Estimated Number of Respondents:
225. Frequency of Response: Twice for
the Semi-Annual Report Form; once for
the Quality Assurance Form.
Estimated Total Annual Hour Burden:
733. Estimated Total Annual Cost:
$37,000 includes $0 annualized capital
or O&M costs and $37,000 annual labor
costs.
Are there changes in the estimates from
the last approval?
Changes in the Estimates: There is no
change in estimate from the last ICR
renewal.
What is the next step in the process for
this ICR?
EPA will consider the comments
received and amend the ICR as
appropriate. The final ICR package will
then be submitted to OMB for review
and approval pursuant to 5 CFR
1320.12. At that time, EPA will issue
another Federal Register notice
pursuant to 5 CFR 1320.5(a)(1)(iv) to
announce the submission of the ICR to
OMB and the opportunity to submit
additional comments to OMB. If you
have any questions about this ICR or the
approval process, please contact the
technical person listed under FOR
FURTHER INFORMATION CONTACT.
Dated: June 22, 2011.
Jeffrey Wells,
Acting Director, Information Exchange &
Services Division.
[FR Doc. 2011–16194 Filed 6–27–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10321]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
collections for public comment.
AGENCY:
PO 00000
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37813
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the Agency’s function;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Early Retiree
Reinsurance Program (ERRP); Use:
Under section 1102 of the Affordable
Care Act and implementing regulations
at 45 CFR part 149, employment-based
plans that offer health benefits to early
retirees and their spouses, surviving
spouses and dependents are eligible
under a temporary program to receive a
tax-free reimbursement for the costs of
certain health benefits for such
individuals (the Early Retiree
Reinsurance Program, or ERRP). In order
to qualify, plan sponsors must submit a
complete application to the U.S.
Department of Health & Human Services
(HHS). In order to receive
reimbursement under the program, they
must also submit documentation of
actual costs for health care benefits,
which consists of documentation of
actual costs for the items and services
involved, and a list of individuals to
whom the documentation applies. Once
HHS reviews and analyzes the
information on the application,
notification will be sent to the plan
sponsor about its eligibility to
participate in the program. Once HHS
reviews and analyzes each
reimbursement request, reimbursement
under the program will be made to the
sponsor, as appropriate. The program’s
funding is limited to $5 billion, and the
program sunsets on January 1, 2014.
As compared with the burden
estimates OMB approved on December
22, 2010, for OMB #0938–1087. There is
a nominal change to burden of 1 hour,
to account for the fact that sponsors
have an obligation to update any
incorrect or outdated information in
their applications. Beyond that, there is
no change to burden. The burden hours
associated with reading the guidance
materials related to disclosing data
inaccuracies that are being included
with this revised PRA submission, and
with completing the Prima Facie
Evidence Cover Sheet that is being
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37814
Federal Register / Vol. 76, No. 124 / Tuesday, June 28, 2011 / Notices
included with this revised PRA
submission, were already accounted for
in the PRA package OMB approved on
December 22, 2010. Specially, the
burden associated with completing the
Prima Facie Evidence cover sheet, was
included in the burden estimate for
submitting a reimbursement request.
The burden associated with reading the
guidance paper on reporting data
inaccuracies was already included in
the burden estimate for disclosing data
inaccuracies. Form Number: CMS–
10321 (OCN: 0938–1087); Frequency:
Occasionally; Affected Public: Private
Sector: Business or other for-profits and
Not-for-profit institutions: State, Local,
or Tribal Governments; Number of
Respondents: 13,200; Number of
Responses; 71,330; Total Annual Hours:
1,927,575. (For policy questions
regarding this collection, contact Dave
Mlawsky at (410) 786–6851. For all
other issues call (410) 786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on July 28, 2011.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS
Desk Officer, Fax Number: (202) 395–
6974, E-mail:
OIRA_submission@omb.eop.gov.
Dated: June 23, 2011.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2011–16233 Filed 6–24–11; 4:15 pm]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0481]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; New Animal Drugs
for Investigational Uses
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the reporting and recordkeeping
requirements for ‘‘New Animal Drugs
for Investigational Uses.’’
DATES: Submit electronic or written
comments on the collection of
information by August 29, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651,
Juanmanuel.vilela@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
SUMMARY:
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Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
New Animal Drugs for Investigational
Uses—21 CFR Part 511 (OMB Control
Number 0910–0117—Extension)
FDA has the authority under the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) to approve new animal
drugs. Section 512(j) of the FD&C Act
(21 U.S.C. 360b(j)) authorizes FDA to
issue regulations relating to the
investigational use of new animal drugs.
The regulations setting forth the
conditions for investigational use of
new animal drugs have been codified at
part 511 (21 CFR part 511). If the new
animal drug is only for tests in vitro or
in laboratory research animals, the
person distributing the new animal drug
must maintain records showing the
name and post office address of the
expert or expert organization to whom
it is shipped and the date, quantity, and
batch or code mark of each shipment
and delivery for a period of 2 years after
such shipment or delivery. Before
shipping a new animal drug for clinical
investigations in animals, a sponsor
must submit to FDA a Notice of Claimed
Investigational Exemption (NCIE). The
NCIE must contain, among other things,
the following specific information: (1)
Identity of the new animal drug, (2)
labeling, (3) statement of compliance of
any non-clinical laboratory studies with
good laboratory practices, (4) name and
address of each clinical investigator, (5)
the approximate number of animals to
be treated or amount of new animal
drug(s) to be shipped, and (6)
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]]>Agencies
[Federal Register Volume 76, Number 124 (Tuesday, June 28, 2011)]
[Notices]
[Pages 37813-37814]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16233]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10321]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid
Services (CMS), Department of Health and Human Services, is publishing
the following summary of proposed collections for public comment.
Interested persons are invited to send comments regarding this burden
estimate or any other aspect of this collection of information,
including any of the following subjects: (1) The necessity and utility
of the proposed information collection for the proper performance of
the Agency's function; (2) the accuracy of the estimated burden; (3)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (4) the use of automated collection techniques or
other forms of information technology to minimize the information
collection burden.
1. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Early Retiree
Reinsurance Program (ERRP); Use: Under section 1102 of the Affordable
Care Act and implementing regulations at 45 CFR part 149, employment-
based plans that offer health benefits to early retirees and their
spouses, surviving spouses and dependents are eligible under a
temporary program to receive a tax-free reimbursement for the costs of
certain health benefits for such individuals (the Early Retiree
Reinsurance Program, or ERRP). In order to qualify, plan sponsors must
submit a complete application to the U.S. Department of Health & Human
Services (HHS). In order to receive reimbursement under the program,
they must also submit documentation of actual costs for health care
benefits, which consists of documentation of actual costs for the items
and services involved, and a list of individuals to whom the
documentation applies. Once HHS reviews and analyzes the information on
the application, notification will be sent to the plan sponsor about
its eligibility to participate in the program. Once HHS reviews and
analyzes each reimbursement request, reimbursement under the program
will be made to the sponsor, as appropriate. The program's funding is
limited to $5 billion, and the program sunsets on January 1, 2014.
As compared with the burden estimates OMB approved on December 22,
2010, for OMB 0938-1087. There is a nominal change to burden
of 1 hour, to account for the fact that sponsors have an obligation to
update any incorrect or outdated information in their applications.
Beyond that, there is no change to burden. The burden hours associated
with reading the guidance materials related to disclosing data
inaccuracies that are being included with this revised PRA submission,
and with completing the Prima Facie Evidence Cover Sheet that is being
[[Page 37814]]
included with this revised PRA submission, were already accounted for
in the PRA package OMB approved on December 22, 2010. Specially, the
burden associated with completing the Prima Facie Evidence cover sheet,
was included in the burden estimate for submitting a reimbursement
request. The burden associated with reading the guidance paper on
reporting data inaccuracies was already included in the burden estimate
for disclosing data inaccuracies. Form Number: CMS-10321 (OCN: 0938-
1087); Frequency: Occasionally; Affected Public: Private Sector:
Business or other for-profits and Not-for-profit institutions: State,
Local, or Tribal Governments; Number of Respondents: 13,200; Number of
Responses; 71,330; Total Annual Hours: 1,927,575. (For policy questions
regarding this collection, contact Dave Mlawsky at (410) 786-6851. For
all other issues call (410) 786-1326.)
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access CMS Web
site address at https://www.cms.hhs.gov/PaperworkReductionActof1995, or
E-mail your request, including your address, phone number, OMB number,
and CMS document identifier, to Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786-1326.
To be assured consideration, comments and recommendations for the
proposed information collections must be received by the OMB desk
officer at the address below, no later than 5 p.m. on July 28, 2011.
OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395-6974, E-mail: OIRA_submission@omb.eop.gov.
Dated: June 23, 2011.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. 2011-16233 Filed 6-24-11; 4:15 pm]
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