Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 72870-72871 [2012-29496]
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Federal Register / Vol. 77, No. 235 / Thursday, December 6, 2012 / Notices
routes, including inhalation, ingestion,
and to a lesser degree absorption
through the skin. Several observational
human studies have reported an
association between exposure to certain
phthalates and adverse developmental
and reproductive effects. The ubiquitous
presence of phthalates in the
environment and the potential
consequences of human exposure to
phthalates have raised concerns,
particularly in vulnerable populations
such as pregnant women and infants.
Although the currently available
human data are limited, the Agency has
determined that there is evidence that
exposure to DBP and DEHP from
pharmaceuticals presents a potential
risk of developmental and reproductive
toxicity. While it is recognized that drug
products may carry inherent risks, DBP
and DEHP are used as excipients, and
safer alternatives are available.
Therefore, the Agency recommends
avoiding the use of DBP and DEHP as
excipients in CDER-regulated drug and
biologic products.
These recommendations apply to
CDER-regulated drug and biologic
products that are under development
(i.e., investigational new drugs),
nonapplication products (e.g., over the
counter monograph products), and both
marketed approved products and those
currently under review for marketing
consideration (i.e., new drug
applications, abbreviated new drug
applications, and biologics license
applications).
There are alternatives to DBP and
DEHP for use as excipients in CDERregulated products. Manufacturers with
products that contain DBP or DEHP
should consider alternative excipients
and determine if the alternative
excipient they plan to use has been used
in similar CDER-approved products and
at what level.
The Inactive Ingredients Database
provides information on excipients
present in FDA-approved drug products,
and this information can be helpful in
developing drug products. As
manufacturers reformulate their
products, the listings for DBP and DEHP
will be removed from the Inactive
Ingredients Database.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on limiting the use of
certain phthalates as excipients in
CDER-regulated products. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
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satisfies the requirements of the
applicable statutes and regulations.
II. Comments
Interested persons may submit either
written comments regarding this
document to the Division of Dockets
Management (see ADDRESSES) or
electronic comments to https://
www.regulations.gov. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520) and have been approved under
OMB control numbers 0910–0014 and
0910–0001.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://www.
regulations.gov.
Dated: November 30, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–29461 Filed 12–5–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
ACTION:
Notice.
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 (44 U.S.C.
Chapter 35), the Health Resources and
Services Administration (HRSA) will
submit an Information Collection
Request (ICR) to the Office of
Management and Budget (OMB).
Comments submitted during the first
SUMMARY:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
public review of this ICR will be
provided to OMB. OMB will accept
further comments from the public
during the review and approval period.
To request a copy of the clearance
requests submitted to OMB for review,
email paperwork@hrsa.gov or call the
HRSA Reports Clearance Office at (301)
443–1984.
Information Collection Request Title:
Health Center Controlled Networks
(OMB No. 0915-xxxx) NEW
Abstract: One goal of the Health
Resources and Services Administration
(HRSA) is to ensure that all Health
Center Program grantees effectively
implement health information
technology (HIT) systems that enable all
providers to become meaningful users of
HIT, including Electronic Health
Records (EHR), and use those systems to
increase access to care, improve quality
of care, and reduce the costs of care
delivered. The Health Center Controlled
Network (HCCN) program serves as a
major component of HRSA’s HIT
initiative to support these goals. The
HCCN model focuses on the integration
of certain functions and the sharing of
skills, resources, and data to improve
health center operations and care
provision, and to generate efficiencies
and economies of scale. Through this
grant, HCCNs will provide support for
the adoption, implementation, and
meaningful use of HIT to improve the
quality of care provided by existing
Health Center Program grantees (i.e.,
Section 330 funded health centers) by
engaging in the following program
components:
• Adoption and Implementation:
Assist participating health centers with
effectively adopting and implementing
certified EHR technology.
• Meaningful Use: Support
participating health centers in meeting
Meaningful Use requirements and
accessing incentive payments under the
Medicare and Medicaid EHR Incentive
Programs.
• Quality Improvement (QI): Advance
participating health centers’ QI
initiatives to improve clinical and
operational quality, including Patient
Centered Medical Home (PCMH)
recognition.
HRSA plans to collect and evaluate
network outcome measures. HRSA also
plans to require that HCCNs report such
measures to HRSA in annual work plan
updates as part of their annual, noncompeting continuation progress reports
through an electronic reporting system.
The work plan updates will include
information on grantees’ plans and
progress on the following:
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Federal Register / Vol. 77, No. 235 / Thursday, December 6, 2012 / Notices
• Adoption and Implementation of
HIT (including EHR);
• Attainment of Meaningful Use
Requirements; and
• QI Measures (e.g., Healthy People
2020 clinical quality measures, PCMH
recognition status, etc.).
The annual, non-competing
continuation progress reports will
describe each grantee’s progress in
achieving key activity goals such as
quality improvement, data access and
exchange, efficiency and effectiveness of
network services, and the ability to track
and monitor patient outcomes, as well
as emerging needs, challenges and
barriers encountered, customer
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
The annual estimate of burden is as
follows:
satisfaction, and plans to meet goals for
the next year. Grantees will submit their
work plan updates and annual, noncompeting continuation progress report
each fiscal year of the grant; the
submission and subsequent HRSA
approval of each report triggers the
budget period renewal and release of
each subsequent year of funding. The
estimated total number of burden hours
is 1662.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
Number of
respondents
Form name
Responses
per
respondent
Total
responses
Hours per
response
Total burden
hours
Work Plan Update ................................................................
Annual Progress Report/Interim Evaluation Progress Report ...................................................................................
30
1
30
10.9
327
30
1
30
44.5
1,335
Total ..............................................................................
30
........................
........................
........................
1,662
Submit your comments to
the desk officer for HRSA either by
email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806. Please direct all
correspondence to the ‘‘attention of the
desk officer for HRSA.’’
Deadline: Comments on this ICR
should be received within 30 days of
this notice.
ADDRESSES:
Dated: November 29, 2012.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2012–29496 Filed 12–5–12; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on DSK4VPTVN1PROD with
Proposed Collection; Comment
Request (60-Day FRN): The
Agricultural Health Study: A
Prospective Cohort Study of Cancer
and Other Disease Among Men and
Women in Agriculture (NCI)
Summary: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
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Written comments and/or suggestions
from the public and affected agencies
are invited to address one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
The quality, utility, and clarity of the
information to be collected; and (4)
Minimize the burden of the collection of
information on those who are to
respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
To submit comments in writing,
request more information on the
proposed project, or to obtain a copy of
the data collection plans and
instruments, contact: Jane Hoppin,
Sc.D., Epidemiology Branch, National
Institute of Environmental Health
Sciences, NIH, 111 T.W. Alexander
Drive, PO Box 12233, MD A3–05,
Research Triangle Park, NC 27709, or
call non-toll-free number 919–541–
7622, or email your request, including
your address to: hoppin1@niehs.nih.gov.
Comments regarding this information
collection are best assured of having
their full effect if received within 60
days of the date of this publication.
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Proposed Collection: The Agricultural
Health Study: A Prospective Cohort
Study of Cancer and Other Disease
Among Men and Women in Agriculture,
0925–0406, Expiration Date 5/31/2013—
REVISION—National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH).
Need and Use of Information
Collection: The purpose of this
information collection is to continue
and complete updating the occupational
and environmental exposure
information as well as medical history
information for licensed pesticide
applicators and their spouses enrolled
in the Agricultural Health Study. This
represents a request to complete phase
IV (2013–2015) of the study and to
continue and complete the buccal cell
collection and the Study of Biomarkers
of Exposures and Effects in Agriculture
(BEEA). The primary objectives of the
study are to determine the health effects
resulting from occupational and
environmental exposures in the
agricultural environment. The phase IV
follow up data will be collected by
using one of three methods of the cohort
member’s choosing: self-administered
computer assisted web survey (CAWI);
self-administered paper-and-pen (Paper/
pen); or an interviewer administered
computer assisted telephone interview
(CATI). Proxy interviews for those
cohort members unable to complete the
follow up will be completed by using
one of the three methods as well.
Secondary objectives include evaluating
E:\FR\FM\06DEN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 235 (Thursday, December 6, 2012)]
[Notices]
[Pages 72870-72871]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29496]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and
Services Administration (HRSA) will submit an Information Collection
Request (ICR) to the Office of Management and Budget (OMB). Comments
submitted during the first public review of this ICR will be provided
to OMB. OMB will accept further comments from the public during the
review and approval period. To request a copy of the clearance requests
submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA
Reports Clearance Office at (301) 443-1984.
Information Collection Request Title: Health Center Controlled Networks
(OMB No. 0915-xxxx) NEW
Abstract: One goal of the Health Resources and Services
Administration (HRSA) is to ensure that all Health Center Program
grantees effectively implement health information technology (HIT)
systems that enable all providers to become meaningful users of HIT,
including Electronic Health Records (EHR), and use those systems to
increase access to care, improve quality of care, and reduce the costs
of care delivered. The Health Center Controlled Network (HCCN) program
serves as a major component of HRSA's HIT initiative to support these
goals. The HCCN model focuses on the integration of certain functions
and the sharing of skills, resources, and data to improve health center
operations and care provision, and to generate efficiencies and
economies of scale. Through this grant, HCCNs will provide support for
the adoption, implementation, and meaningful use of HIT to improve the
quality of care provided by existing Health Center Program grantees
(i.e., Section 330 funded health centers) by engaging in the following
program components:
Adoption and Implementation: Assist participating health
centers with effectively adopting and implementing certified EHR
technology.
Meaningful Use: Support participating health centers in
meeting Meaningful Use requirements and accessing incentive payments
under the Medicare and Medicaid EHR Incentive Programs.
Quality Improvement (QI): Advance participating health
centers' QI initiatives to improve clinical and operational quality,
including Patient Centered Medical Home (PCMH) recognition.
HRSA plans to collect and evaluate network outcome measures. HRSA
also plans to require that HCCNs report such measures to HRSA in annual
work plan updates as part of their annual, non-competing continuation
progress reports through an electronic reporting system. The work plan
updates will include information on grantees' plans and progress on the
following:
[[Page 72871]]
Adoption and Implementation of HIT (including EHR);
Attainment of Meaningful Use Requirements; and
QI Measures (e.g., Healthy People 2020 clinical quality
measures, PCMH recognition status, etc.).
The annual, non-competing continuation progress reports will
describe each grantee's progress in achieving key activity goals such
as quality improvement, data access and exchange, efficiency and
effectiveness of network services, and the ability to track and monitor
patient outcomes, as well as emerging needs, challenges and barriers
encountered, customer satisfaction, and plans to meet goals for the
next year. Grantees will submit their work plan updates and annual,
non-competing continuation progress report each fiscal year of the
grant; the submission and subsequent HRSA approval of each report
triggers the budget period renewal and release of each subsequent year
of funding. The estimated total number of burden hours is 1662.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose, or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
The annual estimate of burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Form name respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Work Plan Update................ 30 1 30 10.9 327
Annual Progress Report/Interim 30 1 30 44.5 1,335
Evaluation Progress Report.....
-------------------------------------------------------------------------------
Total....................... 30 .............. .............. .............. 1,662
----------------------------------------------------------------------------------------------------------------
ADDRESSES: Submit your comments to the desk officer for HRSA either by
email to OIRA_submission@omb.eop.gov or by fax to 202-395-5806. Please
direct all correspondence to the ``attention of the desk officer for
HRSA.''
Deadline: Comments on this ICR should be received within 30 days of
this notice.
Dated: November 29, 2012.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2012-29496 Filed 12-5-12; 8:45 am]
BILLING CODE 4165-15-P
