Agency Information Collection Request. 30-Day Public Comment Request, 27346-27347 [2010-11568]
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27346
Federal Register / Vol. 75, No. 93 / Friday, May 14, 2010 / Notices
ANNUAL ESTIMATED BURDEN HOURS
Average
burden
hours per
response
Number of
respondents
Number of
responses/
respondent
Hospital staff (Training) ...................................................................................................
Hospital staff (data collection) .........................................................................................
State/Territory Preparedness staff (training) ...................................................................
State/Territory Preparedness staff (data collection) ........................................................
6,000
6,000
62
62
1
102
1
102
1
1
1
3
6,000
612,000
62
18,972
Total ..........................................................................................................................
....................
....................
....................
31,154
Type of respondent
Seleda Perryman,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 2010–11567 Filed 5–13–10; 8:45 am]
BILLING CODE 4150–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–NEW; 30day 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
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.
AGENCY:
Total
burden
hours
little about why consumers, and
specifically Medicare beneficiaries, elect
to use PHRs and what functionality they
want from a PHR. Understanding these
needs will be critical if HHS and the
Centers for Medicare & Medicaid
Services (CMS) are to pursue PHRs as a
tool to empower consumers to manage
their health and have the capability to
link to their provider’s EHR.
In January 2009, CMS launched a new
program in Arizona and Utah, the
Medicare PHR Choice Pilot (PHRC).
This pilot encourages Medicare fee-forservice (FFS) beneficiaries to take
advantage of the newer, more robust
Internet-based tools for tracking their
health and health care services. This is
the first pilot to offer a choice of PHRs
to Medicare FFS beneficiaries, including
PHRs with additional functionality and
direct data linkages for the consumers.
Pilot participants can choose among
GoogleHealthTM, NoMoreClipboardTM,
PassportMDTM, and HealthTrioTM,
competitors in the open PHR market.
HHS’ Office of the Assistant Secretary
for Planning and Evaluation (ASPE) has
contracted with Mathematica Policy
Research to conduct an evaluation of
this pilot program, including a PHR
enrollee user satisfaction survey to
assess barriers, facilitators, and
satisfaction with the PHRs. A selfadministered paper-and-pencil
instrument will be the primary data
collection mode for the PHRC user
satisfaction survey, with telephone
followup for mail nonrespondents. The
one-time data collection field period is
expected to be 12 weeks in Fall 2010.
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: Evaluation of
Medicare Personal Health Records
Choice Pilot—OMB No. 0990–NEW—
Office of the Assistant Secretary for
Planning and Evaluation.
Abstract: Since 2003, HHS has
worked toward the goal of establishing
electronic, longitudinal health records
for Americans that can be accessed
safely, across the internet, and anytime
and anywhere by patients, doctors, and
other health care providers. In addition
to electronic health records (EHRs),
where health information is created,
stored and accessed mainly by health
care organizations and practitioners,
personal health records (PHRs),
electronic, patient-centered applications
and services, are gaining increasing
recognition and momentum. Current
PHR business models represent broad
and varied uses, from disease
management to health promotion, with
sponsors consisting of commercial
vendors, heath plans, employers, and
health care providers. We know very
ESTIMATED ANNUALIZED BURDEN TABLE
Number of respondents
Number of responses per
respondent
Average burden hours per
response
Medicare beneficiaries .....................
500
1
25/60
208
...........................................................
500
........................
........................
208
emcdonald on DSK2BSOYB1PROD with NOTICES
Forms
(if necessary)
Type of respondent
Self-administered questionnaire .......
Total ...........................................
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18:07 May 13, 2010
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14MYN1
Total burden
hours
Federal Register / Vol. 75, No. 93 / Friday, May 14, 2010 / Notices
Seleda Perryman,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 2010–11568 Filed 5–13–10; 8:45 am]
BILLING CODE 4150–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0545]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Biological
Products: Reporting of Biological
Product Deviations and Human Cells,
Tissues, and Cellular and TissueBased Product Deviations in
Manufacturing; Form FDA 3486 and
Addendum 3486A
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 June 14,
2010.
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 0910–0458. Also
include the FDA docket number found
in brackets in the heading of this
document.
emcdonald on DSK2BSOYB1PROD with NOTICES
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:
VerDate Mar<15>2010
18:07 May 13, 2010
Jkt 220001
Biological Products: Reporting of
Biological Product Deviations and
Human Cells, Tissues, and Cellular and
Tissue-Based Product Deviations in
Manufacturing; Form FDA 3486 and
Addendum 3486A—(OMB Control
Number 0910–0458)—Extension
Under section 351 of the Public
Health Service Act (PHS Act) (42 U.S.C.
262), all biological products, including
human blood and blood components,
offered for sale in interstate commerce
must be licensed and meet standards,
including those prescribed in the FDA
regulations, designed to ensure the
continued safety, purity, and potency of
such products. In addition under
section 361 of the PHS Act (42 U.S.C.
264), FDA may issue and enforce
regulations necessary to prevent the
introduction, transmission, or spread of
communicable diseases between the
States or possessions or from foreign
countries into the States or possessions.
Further, the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 351)
provides that drugs and devices
(including human blood and blood
components) are adulterated if they do
not conform with current good
manufacturing practice (CGMP) assuring
that they meet the requirements of the
act. Establishments manufacturing
biological products including human
blood and blood components must
comply with the applicable CGMP
regulations (parts 211, 606, and 820 (21
CFR parts 211, 606, and 820)) and
current good tissue practice (CGTP)
regulations (part 1271 (21 CFR part
1271)) as appropriate. FDA regards
biological product deviation (BPD)
reporting and human cells, tissues, and
cellular and tissue-based product (HCT/
P) deviation reporting to be an essential
tool in its directive to protect public
health by establishing and maintaining
surveillance programs that provide
timely and useful information.
Section 600.14, in brief, requires the
manufacturer who holds the biological
product license, for other than human
blood and blood components, and who
had control over a distributed product
when the deviation occurred, to report
to the Center for Biologics Evaluation
and Research (CBER) or to the Center for
Drugs Evaluation and Research (CDER)
as soon as possible but not to exceed 45
calendar days after acquiring
information reasonably suggesting that a
reportable event has occurred. Section
606.171, in brief, requires a licensed
manufacturer of human blood and blood
components, including Source Plasma;
an unlicensed registered blood
establishment; or a transfusion service
who had control over a distributed
PO 00000
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27347
product when the deviation occurred, to
report to CBER as soon as possible but
not to exceed 45 calendar days after
acquiring information reasonably
suggesting that a reportable event has
occurred. Similarly, § 1271.350(b), in
brief, requires non-reproductive HCT/P
establishments described in § 1271.10 to
report to CBER all HCT/P deviations
relating to a distributed HCT/P that
relates to the core CGTP requirements,
if the deviation occurred in the
establishment’s facility or in a facility
that performed a manufacturing step for
the establishment under contract,
agreement or other arrangement. Form
FDA 3486 is used to submit BPD reports
and HCT/P deviation reports.
Respondents to this collection of
information are the licensed
manufacturers of biological products
other than human blood and blood
components, licensed manufacturers of
blood and blood components including
Source Plasma, unlicensed registered
blood establishments, transfusion
services, and establishments that
manufacture non-reproductive HCT/Ps
regulated solely under section 361 of the
PHS Act as described in § 1271.10. The
number of respondents and total annual
responses are based on the BPD reports
and HCT/P deviation reports FDA
received in fiscal year (FY) 2008. The
number of licensed manufacturers and
total annual responses under 21 CFR
600.14 include the estimates for BPD
reports submitted to both CBER and
CDER. Based on the information from
industry, the estimated average time to
complete a deviation report is 2 hours.
The availability of the standardized
report form, Form FDA 3486, and the
ability to submit this report
electronically to CBER (CDER does not
currently accept electronic filings)
further streamlines the report
submission process.
CBER has developed an addendum to
Form FDA 3486. The Web-based
addendum 3486A provides additional
information when a BPD report has been
reviewed by FDA and evaluated as a
possible recall. The additional
information requested includes
information not contained in the Form
FDA 3486 such as: (1) Distribution
pattern, (2) method of consignee
notification, (3) consignee(s) of products
for further manufacture, (4) additional
product information, (5) updated
product disposition, and (6) industry
recall contacts. This information is
requested by CBER through e-mail
notification to the submitter of the BPD
report. This information is used by
CBER for recall classification purposes.
At this time Addendum 3486A is being
used only for those BPD reports
E:\FR\FM\14MYN1.SGM
14MYN1
]]>Agencies
[Federal Register Volume 75, Number 93 (Friday, May 14, 2010)]
[Notices]
[Pages 27346-27347]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-11568]
-----------------------------------------------------------------------
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: Evaluation of Medicare Personal Health Records
Choice Pilot--OMB No. 0990-NEW--Office of the Assistant Secretary for
Planning and Evaluation.
Abstract: Since 2003, HHS has worked toward the goal of
establishing electronic, longitudinal health records for Americans that
can be accessed safely, across the internet, and anytime and anywhere
by patients, doctors, and other health care providers. In addition to
electronic health records (EHRs), where health information is created,
stored and accessed mainly by health care organizations and
practitioners, personal health records (PHRs), electronic, patient-
centered applications and services, are gaining increasing recognition
and momentum. Current PHR business models represent broad and varied
uses, from disease management to health promotion, with sponsors
consisting of commercial vendors, heath plans, employers, and health
care providers. We know very little about why consumers, and
specifically Medicare beneficiaries, elect to use PHRs and what
functionality they want from a PHR. Understanding these needs will be
critical if HHS and the Centers for Medicare & Medicaid Services (CMS)
are to pursue PHRs as a tool to empower consumers to manage their
health and have the capability to link to their provider's EHR.
In January 2009, CMS launched a new program in Arizona and Utah,
the Medicare PHR Choice Pilot (PHRC). This pilot encourages Medicare
fee-for-service (FFS) beneficiaries to take advantage of the newer,
more robust Internet-based tools for tracking their health and health
care services. This is the first pilot to offer a choice of PHRs to
Medicare FFS beneficiaries, including PHRs with additional
functionality and direct data linkages for the consumers. Pilot
participants can choose among GoogleHealthTM,
NoMoreClipboardTM, PassportMDTM, and
HealthTrioTM, competitors in the open PHR market.
HHS' Office of the Assistant Secretary for Planning and Evaluation
(ASPE) has contracted with Mathematica Policy Research to conduct an
evaluation of this pilot program, including a PHR enrollee user
satisfaction survey to assess barriers, facilitators, and satisfaction
with the PHRs. A self-administered paper-and-pencil instrument will be
the primary data collection mode for the PHRC user satisfaction survey,
with telephone followup for mail nonrespondents. The one-time data
collection field period is expected to be 12 weeks in Fall 2010.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Forms (if necessary) Type of Number of responses per hours per Total burden
respondent respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Self-administered Medicare 500 1 25/60 208
questionnaire. beneficiaries.
---------------------------------------------------------------------------------
Total..................... ................ 500 .............. .............. 208
----------------------------------------------------------------------------------------------------------------
[[Page 27347]]
Seleda Perryman,
Office of the Secretary, Paperwork Reduction Act Reports Clearance
Officer.
[FR Doc. 2010-11568 Filed 5-13-10; 8:45 am]
BILLING CODE 4150-05-P
