Agency Information Collection Request. 30-Day Public Comment Request, 55066-55067 [2011-21644]
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55066
Federal Register / Vol. 76, No. 172 / Tuesday, September 6, 2011 / Notices
Proposed Project: The Hospital
Preparedness Program—Generic HPP
and Future Collection Activities—
New—OMB No. 0990–OS—Assistant
Secretary for Preparedness and
Response (ASPR).
Abstract: The Program Evaluation
Section (PES), part of the Department of
Health and Human Services (HHS),
Assistant Secretary for Preparedness
and Response (ASPR), Office of
Preparedness and Emergency
Operations (OPEO), Division of
Preparedness Planning (DPP), in
conjunction with the Hospital
Preparedness Program (HPP) in the
Division of National Healthcare
Preparedness Programs, is seeking
clearance by the Office of Management
of Budget (OMB) for a Generic Data
Collection Form to serve as the
cornerstone of its effort to assess
awardee performance under the HPP
Cooperative Agreement (CA) Program.
Performance data are gathered from
awardees as part of their Mid-Year and
End-of-Year Progress Reports and other
similar information collections (ICs)
which have the same general purpose
(Healthcare Coalitions, Capabilities and
Budget Information), account for
awardee spending and performance on
all activities conducted in pursuit of
achieving the HPP Grant goals.
Additionally, to reduce administrative
burden on awardees, there is a need to
develop reporting forms and templates
that allow awardees and ASPR to more
easily capture the data and other
information already provided in the
grant application at other times during
the yearly grant cycle, and onsite visits
by project and field officers (e.g. prepopulating some elements of the midyear and end-of-year reporting). Such
reporting will systematically capture
relevant information in a format that
allows for easy access and use within a
number of related grant business
processes, including Grants
management, Program and project
management, and performance metrics
and evaluation. A standardized
program-specific application addendum
will facilitate such data retrieval and
decrease overall government
administration costs.
This data collection effort is crucial to
HPP’s decision-making process
regarding the continued existence,
design and funding levels of this
program. Results from these data
analyses enable HPP to monitor
healthcare emergency preparedness and
progress towards national preparedness
goals.
Estimated Annualized Burden Table
ESTIMATED ANNUAL BURDEN HOURS FOR THE GENERIC HPP AND FUTURE COLLECTION ACTIVITIES
Number of
respondents
Data collection activity
Generic and Future Program Data Information Collection(s) ..........
Number of
responses
62
Response time
(hours)
1
58
Total ..........................................................................................
John Teeter,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 2011–21643 Filed 9–2–11; 8:45 am]
BILLING CODE 4150–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–new; 30-day
notice]
Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Secretary, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Office of the Secretary (OS), Department
of Health and Human Services, is
publishing the following summary of a
proposed collection for public
comment. Interested persons are invited
to send comments regarding this burden
estimate or any other aspect of this
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AGENCY:
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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 functions;
(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.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, e-mail your request,
including your address, phone number,
OMB number, and OS document
identifier, to
Sherette.funncoleman@hhs.gov, or call
the Reports Clearance Office on (202)
690–5683. Send written comments and
recommendations for the proposed
information collections within 30 days
of this notice directly to the OS OMB
PO 00000
Total annual
burden hours
(for all awardees)
Sfmt 4703
Desk Officer; faxed to OMB at 202–395–
5806.
Proposed Project: National Survey of
Single Parent Caregivers—OMB No.
0990–NEW–OWH; HHS, Office on
Women’s Health.
Abstract: The National Survey of
Single Parent Caregivers will measure
the size, characteristics, and unmet
needs of single parents providing care
for an adult family member or friend.
Single parent caregivers provide support
services and financial assistance for two
generations without the aid of a married
partner. Survey results will be used to
develop national estimates of the costs
borne by single parent caregivers, their
psychosocial burden, stress, and
diminished social and leisure
opportunities, and suggest policy
options that mitigate the burden on
single parent caregivers. The survey will
be administered once under a one-year
request, and will contact individuals
using computer-assisted telephone
interviewing (CATI) methods.
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Federal Register / Vol. 76, No. 172 / Tuesday, September 6, 2011 / Notices
55067
ESTIMATED ANNUALIZED BURDEN TABLE
Form
Type of respondent
Number of
respondents
Number of
responses per
respondent
Average burden
hours per
response
Total burden
hours
Single Parent Caregiver Survey
Instrument.
Single Parent Caregivers .........
1,000
1
20/60
333
John Teeter,
Office of the Secretary, Paperwork Reduction
Act Clearance Officer.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2011–21644 Filed 9–2–11; 8:45 am]
Food and Drug Administration
BILLING CODE 4150–33–P
[Docket No. FDA–2011–N–0447]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Advisory Committee on
Minority Health; Cancellation
Office of Minority Health,
Office of the Assistant Secretary for
Health, Office of the Secretary,
Department of Health and Human
Services.
AGENCY:
ACTION:
AGENCY:
ACTION:
A notice was published in the
Federal Register on Tuesday, July 5,
2011, Vol. 76, No. 128, to announce that
a meeting of the Advisory Committee on
Minority Health (ACMH) was scheduled
to be held on Monday, August 29, 2011
from 9 a.m. to 5 p.m., and Tuesday,
August 30, 2011, from 9 a.m. to 1 p.m.
This meeting has been cancelled in its
entirety. The meeting was cancelled
because of the weather projections that
the Washington, DC metropolitan area
would be affected by a significant
hurricane. The meeting was cancelled to
ensure the safety of the Committee
members, Federal staff, and all other
interested parties. Information about
this meeting being rescheduled will be
posted on the Committee’s Web site,
which can be accessed at https://
minorityhealth.hhs.gov.
SUMMARY:
Ms.
Monica A. Baltimore, Executive
Director, ACMH; Suite 600 Tower
Building, 1101 Wootton Parkway,
Rockville, MD 20852. Telephone: (240)
453–2882; Fax: (240) 453–2883.
mstockstill on DSK4VPTVN1PROD with NOTICES
Dated: August 30, 2011.
Monica Baltimore,
Executive Director, Advisory Committee on
Minority Health, Office of Minority Health,
Office of the Assistant Secretary for Health.
[FR Doc. 2011–22659 Filed 9–2–11; 8:45 am]
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Food and Drug Administration,
HHS.
Notice; Cancellation.
FOR FURTHER INFORMATION CONTACT:
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Formal Dispute
Resolution: Scientific and Technical
Issues Related to Pharmaceutical
Current Good Manufacturing Practice
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 October 6,
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 0910–0563. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
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.
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
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Fmt 4703
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Guidance for Industry on Formal
Dispute Resolution: Scientific and
Technical Issues Related to
Pharmaceutical Current Good
Manufacturing Practice—(OMB Control
Number 0910–0563)—Extension
The guidance is intended to provide
information to manufacturers of
veterinary and human drugs, including
human biological drug products, on
how to resolve disputes of scientific and
technical issues relating to current good
manufacturing practice (CGMP).
Disputes related to scientific and
technical issues may arise during FDA
inspections of pharmaceutical
manufacturers to determine compliance
with CGMP requirements, or during
FDA’s assessment of corrective actions
undertaken as a result of such
inspections. The guidance provides
procedures that encourage open and
prompt discussion of disputes and lead
to their resolution. The guidance
describes procedures for raising such
disputes to the Office of Regulatory
Affairs (ORA) and center levels and for
requesting review by the dispute
resolution (DR) Panel.
When a scientific or technical issue
arises during an FDA inspection, the
manufacturer should initially attempt to
reach agreement on the issue informally
with the investigator. Certain scientific
or technical issues may be too complex
or time consuming to resolve during the
inspection. If resolution of a scientific or
technical issue is not accomplished
through informal mechanisms prior to
the issuance of the FDA Form 483, the
manufacturer can formally request DR
and can use the formal two-tiered DR
process described in the guidance.
Tier-one of the formal DR process
involves scientific or technical issues
raised by a manufacturer to the ORA
and center levels. If a manufacturer
disagrees with the tier-one decision,
tier-two of the formal DR process would
then be available for appealing that
decision to the DR panel.
The written request for formal DR to
the appropriate ORA unit should be
made within 30 days of the completion
of an inspection, and should include all
supporting documentation and
arguments for review, as described in
this document. The written request for
formal DR to the DR Panel should be
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]]>Agencies
[Federal Register Volume 76, Number 172 (Tuesday, September 6, 2011)]
[Notices]
[Pages 55066-55067]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21644]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-new; 30-day notice]
Agency Information Collection Request. 30-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Office of the Secretary (OS),
Department of Health and Human Services, is publishing the following
summary of a proposed collection 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
functions; (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.
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, e-mail your
request, including your address, phone number, OMB number, and OS
document identifier, to Sherette.funncoleman@hhs.gov, or call the
Reports Clearance Office on (202) 690-5683. Send written comments and
recommendations for the proposed information collections within 30 days
of this notice directly to the OS OMB Desk Officer; faxed to OMB at
202-395-5806.
Proposed Project: National Survey of Single Parent Caregivers--OMB
No. 0990-NEW-OWH; HHS, Office on Women's Health.
Abstract: The National Survey of Single Parent Caregivers will
measure the size, characteristics, and unmet needs of single parents
providing care for an adult family member or friend. Single parent
caregivers provide support services and financial assistance for two
generations without the aid of a married partner. Survey results will
be used to develop national estimates of the costs borne by single
parent caregivers, their psychosocial burden, stress, and diminished
social and leisure opportunities, and suggest policy options that
mitigate the burden on single parent caregivers. The survey will be
administered once under a one-year request, and will contact
individuals using computer-assisted telephone interviewing (CATI)
methods.
[[Page 55067]]
Estimated Annualized Burden Table
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Form Type of respondent Number of responses per hours per Total burden
respondents respondent response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Single Parent Caregiver Survey Instrument... Single Parent Caregivers...... 1,000 1 20/60 333
--------------------------------------------------------------------------------------------------------------------------------------------------------
John Teeter,
Office of the Secretary, Paperwork Reduction Act Clearance Officer.
[FR Doc. 2011-21644 Filed 9-2-11; 8:45 am]
BILLING CODE 4150-33-P
