Agency Information Collection Activities: Proposed Collection: Comment Request, 39711-39712 [2012-16332]
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Federal Register / Vol. 77, No. 129 / Thursday, July 5, 2012 / Notices
acetaminophen of the circumstances in
which FDA intends to exercise
enforcement discretion with regard to
the liver warning required in the
labeling.
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by September 4,
2012.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Tina
Walther, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 5108, Silver Spring,
MD 20993–0002, 301–796–5086.
SUPPLEMENTARY INFORMATION:
DATES:
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I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Organ-Specific Warnings: Internal
Analgesic, Antipyretic, and
Antirheumatic Drug Products for Overthe-Counter Human Use—Labeling for
Products That Contain
Acetaminophen.’’ In the Federal
Register of December 26, 2006 (71 FR
77314), FDA published a proposed rule
on organ-specific warnings and related
labeling for OTC IAAA drug products.
In the Federal Register of April 29, 2009
(74 FR 19385), FDA published the final
rule (2009 final rule). In the Federal
Register of November 25, 2009 (74 FR
61512), FDA published a technical
amendment to clarify several provisions
in response to industry feedback. The
2009 final rule, as amended, changed
some of the labeling requirements for
OTC IAAA drug products to inform
consumers about the risk of liver injury
when using acetaminophen and the risk
of stomach bleeding when using
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nonsteroidal anti-inflammatory drugs. It
went into effect April 29, 2010.
The labeling for OTC IAAA products
that contain acetaminophen and are
labeled for adults only, must include the
following liver warning:
Liver warning: This product contains
acetaminophen. Severe liver damage may
occur if you take • more than [insert
maximum number of daily dosage units] in
24 hours, which is the maximum daily
amount [optional: ‘‘For this product’’] • with
other drugs containing acetaminophen • 3 or
more alcoholic drinks every day while using
this product.
Although the currently proposed total
daily dose of acetaminophen is 4,000
milligrams (mg), some OTC IAAA
products that contain acetaminophen
have directions for use that provide a
maximum daily dose of acetaminophen
for the product that is less than 4,000
mg. For example, for some OTC IAAA
drug products that contain both
acetaminophen and one or more other
active ingredients, the maximum
number of daily dosage units might be
limited by an active ingredient other
than acetaminophen, which could result
in a maximum daily dose of
acetaminophen that is less than 4,000
mg for that product. The optional
statement, ‘‘for this product,’’ in the first
bullet of the liver warning is intended
to address these situations, by clarifying
that the maximum number of daily
dosage units for a product might not
reflect the maximum daily dose of
acetaminophen.
However, the Agency understands
that in certain circumstances, despite
this optional statement, the wording of
the first bulleted warning might be
interpreted as indicating that severe
liver damage is associated with a total
daily dose of acetaminophen that is less
than 4,000 mg. This suggestion is not
the intent of the requirement that the
liver warning be included in the
labeling. To address this potential
confusion, the Agency intends to
exercise enforcement discretion with
respect to the liver warning required in
the circumstances described in this draft
guidance.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on this topic. 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 satisfies the
requirements of the applicable statutes
and regulations.
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39711
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. 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.
III. 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: June 21, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–16244 Filed 7–3–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c) (2) (A) of Title 44,
United States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1984.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the Agency; (b) the accuracy of the
Agency’s estimate of the burden of the
proposed collection of information;
(c) ways to enhance 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
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39712
Federal Register / Vol. 77, No. 129 / Thursday, July 5, 2012 / Notices
or other forms of information
technology.
Proposed Project: Health Center
Controlled Networks (OMB No. 0915–
xxxx)—[New]
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 (EHRs), 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 generating efficiencies and
economies of scale. Through this grant,
HCCNs will provide support for the
adoption, implementation, and
meaningful use of Health Information
Technology (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 Electronic
Health Records Incentive Programs.
• Quality Improvement: 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
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:
Number of
respondents
Instrument
Responses
per
respondent
• Adoption and Implementation of
HIT (including EHR);
• Attainment of Meaningful Use
Requirements; and
• Quality improvement 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, 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 750.
The annual estimate of burden is as
follows:
Total
responses
Total
burden
hours
Hours per
response
Work Plan Update ................................................................
Annual Progress Report/Interim Evaluation Progress Report ...................................................................................
30
1
30
5
150
30
1
30
20
600
Total ..............................................................................
60
........................
........................
........................
750
Email comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–29,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
should be received within 60 days of
this notice.
Dated: June 28, 2012.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2012–16332 Filed 7–3–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposal and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposal, the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
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Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; National Children’s
Study Vanguard 2.0.
Date: July 23, 2012.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW.,
Washington, DC 20015.
Contact Person: Sathasiva B. Kandasamy,
Ph.D., Scientific Review Officer, Division of
Scientific Review, National Institute Of Child
Health and Human Development, 6100
Executive Boulevard, Rockville, MD 20892–
9304, (301) 435–6680,
skandasa@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
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[Federal Register Volume 77, Number 129 (Thursday, July 5, 2012)]
[Notices]
[Pages 39711-39712]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-16332]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Comment Request
In compliance with the requirement for opportunity for public
comment on proposed data collection projects (section 3506(c) (2) (A)
of Title 44, United States Code, as amended by the Paperwork Reduction
Act of 1995, Pub. L. 104-13), the Health Resources and Services
Administration (HRSA) publishes periodic summaries of proposed projects
being developed for submission to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995. To request more
information on the proposed project or to obtain a copy of the data
collection plans and draft instruments, email paperwork@hrsa.gov or
call the HRSA Reports Clearance Officer at (301) 443-1984.
Comments are invited on: (a) The proposed collection of information
for the proper performance of the functions of the Agency; (b) the
accuracy of the Agency's estimate of the burden of the proposed
collection of information; (c) ways to enhance 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
[[Page 39712]]
or other forms of information technology.
Proposed Project: Health Center Controlled Networks (OMB No. 0915-
xxxx)--[New]
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 (EHRs), 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 generating efficiencies and economies of scale.
Through this grant, HCCNs will provide support for the adoption,
implementation, and meaningful use of Health Information Technology
(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 Electronic Health Records Incentive
Programs.
Quality Improvement: 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
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:
Adoption and Implementation of HIT (including EHR);
Attainment of Meaningful Use Requirements; and
Quality improvement 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 750.
The annual estimate of burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Instrument respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Work Plan Update................ 30 1 30 5 150
Annual Progress Report/Interim 30 1 30 20 600
Evaluation Progress Report.....
-------------------------------------------------------------------------------
Total....................... 60 .............. .............. .............. 750
----------------------------------------------------------------------------------------------------------------
Email comments to paperwork@hrsa.gov or mail the HRSA Reports
Clearance Officer, Room 10-29, Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments should be received within 60 days
of this notice.
Dated: June 28, 2012.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2012-16332 Filed 7-3-12; 8:45 am]
BILLING CODE 4165-15-P
