Agency Information Collection Activities: Proposed Collection: Public Comment Request, 13311-13312 [2014-05137]
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emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 46 / Monday, March 10, 2014 / Notices
In January 2009, FDA held a joint
meeting of the Anesthetic and Life
Support Drugs Advisory Committee and
the Drug Safety and Risk Management
Advisory Committee to address the
safety and efficacy of propoxyphene and
propoxyphene combination products for
the treatment of mild to moderate pain.
The committee members voted 14 to 12
against the continued marketing of
propoxyphene products but noted that
additional information about the drug’s
cardiac effects would be relevant in
weighing its risks and benefits. Using
authority under the Food and Drug
Administration Amendments Act of
2007 (Pub. L. 110–85), FDA required
Xanodyne to conduct a safety study of
the effects of propoxyphene on the heart
at higher than recommended doses.
Before proceeding with the cardiac
safety study, the company first
conducted a study on healthy
volunteers to determine an appropriate
dose. In this study, the healthy
volunteers in one group were given a
total daily dose of 600 mg of
propoxyphene (the maximum approved
dose), and volunteers in the second
group were given a total daily dose of
900 mg (a dose higher than
recommended in product labeling). The
results showed that there were
significant changes to the electrical
activity of the heart (prolonged PR
interval, widened QRS complex, and
prolonged QT interval), at both the 600
and 900 mg doses. These changes,
which can be seen on an
electrocardiogram, can increase the risk
for serious abnormal heart rhythms. In
light of these new scientific findings,
CDER determined the postmarketing
safety signals for this drug have taken
on new importance, and the overall
balance of risk and benefit can no longer
be considered favorable. Memoranda
explaining CDER’s determination are
available on FDA’s Web site and will be
placed in Docket No. FDA–2014–N–
0199 (Refs. 1 and 2).
On November 19, 2010, FDA issued a
Drug Safety Communication
recommending against the continued
prescription and use of propoxyphene
drug products. This recommendation
was based on all available data,
including the new data showing that
when propoxyphene is taken at
therapeutic doses, it can cause
significant changes to the electrical
activity of the heart. FDA has concluded
that this safety risk outweighs
propoxyphene’s benefits for pain relief
at recommended doses. Based on this
information, FDA asked the
manufacturers of currently marketed
propoxyphene products to voluntarily
remove their products from the market.
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18:00 Mar 07, 2014
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Therefore, based on all available data,
notice is given to the holders of the
approved applications listed in Table 1
and to all other interested persons that
the Director of CDER proposes to issue
an order, under section 505(e) of the
FD&C Act, withdrawing approval of the
applications, amendments, and
supplements upon the grounds that
scientific data show the listed drugs are
unsafe under the conditions of use for
which they were approved.
II. Hearing Procedures
In accordance with section 505(e) of
the FD&C Act, the applicants are hereby
provided an opportunity to request a
hearing to show why approval of the
applications listed in Table 1 should not
be withdrawn and an opportunity to
raise, for administrative determination,
all issues relating to the legal status of
the drug products covered by these
applications.
An applicant who decides to seek a
hearing must file the following: (1) A
written notice of participation and
request for hearing (see DATES) and (2)
the data, information, and analyses
relied on to demonstrate that there is a
genuine and substantial issue of fact
that requires a hearing to resolve (see
DATES). Any other interested person may
also submit comments on this notice.
The procedures and requirements
governing this notice of opportunity for
a hearing, notice of participation and
request for a hearing, the information
and analyses to justify a hearing, other
comments, and a grant or denial of a
hearing are contained in § 314.200 (21
CFR 314.200) and in 21 CFR part 12.
The failure of an applicant to file a
timely written notice of participation
and request for a hearing, as required by
§ 314.200, constitutes an election by that
applicant not to avail itself of the
opportunity for a hearing concerning
CDER’s proposal to withdraw approval
of the applications and constitutes a
waiver of any contentions concerning
the legal status of the drug products.
FDA will then withdraw approval of the
applications, and the drug products may
not thereafter be lawfully introduced or
delivered for introduction into interstate
commerce. Any new drug product
introduced or delivered for introduction
into interstate commerce without an
approved application is subject to
regulatory action at any time.
A request for a hearing may not rest
upon mere allegations or denials, but
must present specific facts showing that
there is a genuine and substantial issue
of fact that requires a hearing. If a
request for a hearing is not complete or
is not supported, the Commissioner of
Food and Drugs will enter summary
PO 00000
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13311
judgment against the person who
requests the hearing, making findings
and conclusions, and denying a hearing.
All submissions under this notice of
opportunity for a hearing must be filed
in four copies. Except for data and
information prohibited from public
disclosure under 21 U.S.C. 331(j) or 18
U.S.C. 1905, the submissions may be
seen in the Division of Dockets
Management (see ADDRESSES) between 9
a.m. and 4 p.m., Monday through
Friday, and will be posted to the docket
at https://www.regulations.gov.
This notice is issued under section
505(e) of the FD&C Act and under the
authority delegated to the Director of
CDER by the Commissioner of Food and
Drugs.
III. References
FDA has placed the following
references on display in the Division of
Dockets Management (see ADDRESSES).
They may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov.
1. Memorandum to Dr. Woodcock:
Recommendation on a Regulatory Decision
for Propoxyphene-Containing Products
(November 18, 2010, Hertz and Avigan);
https://www.fda.gov/downloads/Drugs/
DrugSafety/
PostmarketDrugSafetyInformation
forPatientsandProviders/UCM234349.pdf.
2. Memorandum to Dr. Woodcock on
Propoxyphene-Containing Products
(November 18, 2010, Rappaport); https://
www.fda.gov/downloads/Drugs/DrugSafety/
PostmarketDrugSafetyInformation
forPatientsandProviders/UCM234340.pdf.
Dated: March 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–05062 Filed 3–7–14; 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: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
SUMMARY:
E:\FR\FM\10MRN1.SGM
10MRN1
13312
Federal Register / Vol. 79, No. 46 / Monday, March 10, 2014 / Notices
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received
within 60 days of this notice.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10–29, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: 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 Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Data Collection Tool for Rural Health
Community-Based Grant Programs
OMB No.: 0915–0319—Revision
Abstract: There are currently five
rural health grant programs that operate
under the authority of section 330A of
the Public Health Service (PHS) Act.
These programs include: (1) Rural
Health Care Services Outreach Grant
Program (Outreach); (2) Rural Health
Network Development Grant Program
(Network Development); (3) Small
Healthcare Provider Quality Grant
Program (Quality); (4) Delta States Rural
Development Network Grant Program
(Delta); and (5) Rural Health Network
Development Planning Grant Program
(Network Planning). These grants are to
provide expanded delivery of health
care services in rural areas, for the
planning and implementation of
integrated health care networks in rural
areas, and for the planning and
implementation of quality improvement
and workforce activities. In general, the
grants may be used to expand access,
coordinate, and improve the quality of
essential health care services and
enhance the delivery of health care in
rural areas.
Need and Proposed Use of the
Information: For these programs,
performance measures were drafted to
provide data useful to the programs and
to enable HRSA to provide aggregate
program data required by Congress
under the Government Performance and
Results Act (GPRA) of 1993. These
measures cover the principal topic areas
of interest to ORHP, including: (a)
Access to care; (b) the underinsured and
Number of
respondents
Form name
Rural Health Care Services Outreach Grant Program
Measures ..........................................................................
Rural Health Network Development Grant Program Measures ...................................................................................
Delta States Rural Development Network Grant Program ..
Small Health Care Provider Quality Improvement Grant
Program ............................................................................
Rural Health Network Development Planning Grant Program Measures ................................................................
emcdonald on DSK67QTVN1PROD with NOTICES
18:55 Mar 07, 2014
Jkt 232001
71
2
142
20
12
1
1
20
12
5
6
100
72
30
2
60
10
600
21
1
21
1
21
154
........................
184
........................
935
Dated: February 28, 2014.
Jackie Painter,
Deputy Director, Division of Policy and
Information Coordination.
[FR Doc. 2014–05137 Filed 3–7–14; 8:45 am]
BILLING CODE 4165–15–P
PO 00000
Total burden
hours
1
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
Health Resources and Services
Administration, HHS.
AGENCY:
ACTION:
VerDate Mar<15>2010
Average
burden per
response
(in hours)
Total
responses
71
Total ..............................................................................
HRSA specifically requests comments
on: (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.
Number of
responses per
respondent
uninsured; (c) workforce recruitment
and retention; (d) sustainability; (e)
health information technology; (f)
network development; and (g) health
related clinical measures. Several
measures will be used for all six
programs. All measures will speak to
the ORHP’s progress toward meeting the
goals set.
Likely Respondents: Award recipients
of the programs under the section 330A
of the Public Health Service Act.
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 Information
Collection Request are summarized in
the table below.
Total Estimated Annualized Burden
Hours:
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]]>Agencies
[Federal Register Volume 79, Number 46 (Monday, March 10, 2014)]
[Notices]
[Pages 13311-13312]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05137]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects (Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995), the Health Resources and Services
[[Page 13312]]
Administration (HRSA) announces plans to submit an Information
Collection Request (ICR), described below, to the Office of Management
and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks
comments from the public regarding the burden estimate, below, or any
other aspect of the ICR.
DATES: Comments on this Information Collection Request must be received
within 60 days of this notice.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance Officer, Room 10-29, Parklawn
Building, 5600 Fishers Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: 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
Information Collection Clearance Officer at (301) 443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: Data Collection Tool for
Rural Health Community-Based Grant Programs
OMB No.: 0915-0319--Revision
Abstract: There are currently five rural health grant programs that
operate under the authority of section 330A of the Public Health
Service (PHS) Act. These programs include: (1) Rural Health Care
Services Outreach Grant Program (Outreach); (2) Rural Health Network
Development Grant Program (Network Development); (3) Small Healthcare
Provider Quality Grant Program (Quality); (4) Delta States Rural
Development Network Grant Program (Delta); and (5) Rural Health Network
Development Planning Grant Program (Network Planning). These grants are
to provide expanded delivery of health care services in rural areas,
for the planning and implementation of integrated health care networks
in rural areas, and for the planning and implementation of quality
improvement and workforce activities. In general, the grants may be
used to expand access, coordinate, and improve the quality of essential
health care services and enhance the delivery of health care in rural
areas.
Need and Proposed Use of the Information: For these programs,
performance measures were drafted to provide data useful to the
programs and to enable HRSA to provide aggregate program data required
by Congress under the Government Performance and Results Act (GPRA) of
1993. These measures cover the principal topic areas of interest to
ORHP, including: (a) Access to care; (b) the underinsured and
uninsured; (c) workforce recruitment and retention; (d) sustainability;
(e) health information technology; (f) network development; and (g)
health related clinical measures. Several measures will be used for all
six programs. All measures will speak to the ORHP's progress toward
meeting the goals set.
Likely Respondents: Award recipients of the programs under the
section 330A of the Public Health Service Act.
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 Information Collection Request are summarized in the table below.
Total Estimated Annualized Burden Hours:
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Rural Health Care Services 71 1 71 2 142
Outreach Grant Program Measures
Rural Health Network Development 20 1 20 5 100
Grant Program Measures.........
Delta States Rural Development 12 1 12 6 72
Network Grant Program..........
Small Health Care Provider 30 2 60 10 600
Quality Improvement Grant
Program........................
Rural Health Network Development 21 1 21 1 21
Planning Grant Program Measures
-------------------------------------------------------------------------------
Total....................... 154 .............. 184 .............. 935
----------------------------------------------------------------------------------------------------------------
HRSA specifically requests comments on: (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.
Dated: February 28, 2014.
Jackie Painter,
Deputy Director, Division of Policy and Information Coordination.
[FR Doc. 2014-05137 Filed 3-7-14; 8:45 am]
BILLING CODE 4165-15-P
