Trials to Verify and Describe Clinical Benefit of Midodrine Hydrochloride; Establishment of Public Docket, 1620-1621 [2011-355]
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Federal Register / Vol. 76, No. 7 / Tuesday, January 11, 2011 / Notices
review process to inform their own
system development efforts.
No small businesses will be involved
in this data collection effort.
Respondents: Title IV–E Agencies.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
SACWIS Assessment Review Guide (SARG) .................................................
3
1
250
750
Estimated Total Annual Burden
Hours: 750.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
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 or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–332 Filed 1–10–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0637]
Trials to Verify and Describe Clinical
Benefit of Midodrine Hydrochloride;
Establishment of Public Docket
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
opening of a public docket to provide a
forum to facilitate communication
regarding the conduct of clinical trials
needed to verify and describe the
clinical benefit of midodrine
hydrochloride (HCl) when used to treat
symptomatic orthostatic hypotension.
DATES: Submit either electronic or
written comments by July 11, 2011.
ADDRESSES: Submit electronic
comments 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. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Wei
Lu, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6196, Silver Spring,
MD 20993–0002, e-mail:
Wei.Lu@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA
approved PROAMATINE (midodrine
HCl) for marketing under its accelerated
approval regulations, 21 CFR part 314,
subpart H, on September 6, 1996, to
treat patients with symptomatic
orthostatic hypotension. Since that time,
FDA has approved five generic versions
of this product. Orthostatic hypotension
is a condition in which patients are
unable to maintain blood pressure in the
upright position and become dizzy or
faint upon standing. Subpart H allows
approval of drugs to treat serious or lifethreatening illnesses based on adequate
SUMMARY:
PO 00000
Frm 00029
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and well-controlled clinical trials
establishing that the drug has an effect
on a surrogate endpoint that is
reasonably likely to predict clinical
benefit or based on a clinical endpoint
other than survival or irreversible
morbidity. Approval of PROAMATINE
was based on trials demonstrating that
PROAMATINE increased 1-minute
standing systolic blood pressure, a
surrogate marker considered likely to
correspond to a clinical benefit,
principally relief of symptoms of
orthostatic hypotension and improved
ability to perform life activities.
The subpart H regulations specify that
approvals based upon surrogate
endpoints are ‘‘subject to the
requirement that the applicant study the
drug further to verify and describe its
clinical benefit’’ in postmarketing
studies. The postmarketing study
requirement for midodrine HCl was
described in the new drug application
(NDA) submission seeking its approval
and referenced in the Agency’s 1996
approval letter. In the time since
PROAMATINE was approved, the NDA
holder has sponsored clinical trials and
information regarding the drug’s
efficacy has been published, but data
submitted to the Agency have not
verified the drug’s clinical benefit to
FDA’s satisfaction. Accordingly, on
August 16, 2010, FDA issued a notice of
opportunity for a hearing (NOOH) on a
proposal to withdraw approval of the
NDA for midodrine HCl.
Although the NOOH process is
proceeding on a separate track, FDA
recognizes that existing and potential
sponsors may wish to conduct the
clinical trials needed to support
continued marketing authorization of
midodrine HCl. To assist sponsors in
planning and designing such trials, we
are placing in the docket a brief
description of a recommended clinical
trial design. We are also inviting
interested parties to submit information
to the docket such as any existing
controlled studies that verify the
clinical benefit of midodrine HCl when
used to treat orthostatic hypotension.
Physicians who treat orthostatic
hypotension and patient organizations
that would like to work with any
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Federal Register / Vol. 76, No. 7 / Tuesday, January 11, 2011 / Notices
sponsors of new clinical trials are
invited to submit correspondence to the
docket identifying themselves. We
anticipate that any sponsor planning to
conduct new clinical studies may
contact interested physicians and
organizations to solicit information and
suitable volunteer test subjects.
The public docket is available for
public review in the Division of Dockets
Management (see ADDRESSES) between 9
a.m. and 4 p.m., Monday through
Friday.
Dated: January 6, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2011–355 Filed 1–10–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; NIH Toolbox for Assessment
of Neurological and Behavioral
Function
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 Institute on Aging (NIA), 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.
Proposed Collection: Title: NIH
Toolbox for Assessment of Neurological
and Behavioral Function. Type of
Information Collection Request: New.
Need and Use of Information Collection:
The overall goal of the NIH Toolbox
project is to develop unified, integrated
methods and measures of four domains
of neurological and behavioral
functioning (cognitive, emotional, motor
SUMMARY:
Estimated
number of
respondents
Type of respondents
and sensory) for use in large
longitudinal or epidemiological studies
where functioning is monitored over
time. The current phase (‘‘Norming’’),
will involve a large sample of 12,900 for
the purpose of establishing comparative
norms. Existing recruitment databases
will be randomly sampled and screened
for household members’ age, gender,
race/ethnicity, education and primary
language. The targeted population will
be non-institutionalized U.S. residents,
aged 3–85, with 70% English-speaking
and 30% Spanish-speaking. Frequency
of Response: Once or twice (depending
on subsample). Affected Public:
Individuals. Type of Respondents: U.S.
residents (persons aged 3–85 years). The
annual reporting burden is as follows:
Estimated Number of Respondents:
12,900; Estimated Number of Responses
per Respondent: 1–2; Average Burden
Hours per Response: 1.96; and
Estimated Total Annual Burden Hours
Requested: 29,700. The annualized cost
to respondents is estimated at: $414,375.
There are no Capital Costs, Operating
Costs, and/or Maintenance Costs to
report.
Estimated
number of
responses per
respondent
Average
burden hours
per response
Estimated total
annual burden
hours
requested
Adults *
Adult study participants, single assessment ....................................................
Adult study participants, two assessments ......................................................
Parent proxies for child participants, single assessment ................................
Parent proxies for child participants, two assessments ..................................
3,150
750
3,750
750
1
2
1
2
3
3
0.5
0.5
9,450
4,500
1,875
750
Single assessment ...........................................................................................
Two assessments ............................................................................................
3,750
750
1
2
2.5
2.5
9,375
3,750
Totals ........................................................................................................
* 12,900
........................
........................
29,700
Children
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* Some adults may participate both as a study participant and as a parent proxy if their child is also a study participant.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on 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) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and
(4) Ways to minimize the burden of the
collection of information on those who
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17:33 Jan 10, 2011
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are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Eddie Billingslea,
PhD, Division of Neuroscience, National
Institute on Aging, NIH, DHHS, 7201
Wisconsin Avenue, Suite 350, Bethesda,
Maryland 20892–9205 or call non-tollfree number 301–496–9350 or e-mail
your request, including your address to:
billingsleae@nia.nih.gov.
Dated: January 4, 2011.
Melissa Fraczkowski,
National Institute on Aging, Project Clearance
Liaison, National Institutes of Health.
FOR FURTHER INFORMATION CONTACT:
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]]>Agencies
[Federal Register Volume 76, Number 7 (Tuesday, January 11, 2011)]
[Notices]
[Pages 1620-1621]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-355]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0637]
Trials to Verify and Describe Clinical Benefit of Midodrine
Hydrochloride; Establishment of Public Docket
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
opening of a public docket to provide a forum to facilitate
communication regarding the conduct of clinical trials needed to verify
and describe the clinical benefit of midodrine hydrochloride (HCl) when
used to treat symptomatic orthostatic hypotension.
DATES: Submit either electronic or written comments by July 11, 2011.
ADDRESSES: Submit electronic comments 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. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Wei Lu, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6196, Silver Spring, MD 20993-0002, e-mail: Wei.Lu@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA approved PROAMATINE (midodrine HCl) for
marketing under its accelerated approval regulations, 21 CFR part 314,
subpart H, on September 6, 1996, to treat patients with symptomatic
orthostatic hypotension. Since that time, FDA has approved five generic
versions of this product. Orthostatic hypotension is a condition in
which patients are unable to maintain blood pressure in the upright
position and become dizzy or faint upon standing. Subpart H allows
approval of drugs to treat serious or life-threatening illnesses based
on adequate and well-controlled clinical trials establishing that the
drug has an effect on a surrogate endpoint that is reasonably likely to
predict clinical benefit or based on a clinical endpoint other than
survival or irreversible morbidity. Approval of PROAMATINE was based on
trials demonstrating that PROAMATINE increased 1-minute standing
systolic blood pressure, a surrogate marker considered likely to
correspond to a clinical benefit, principally relief of symptoms of
orthostatic hypotension and improved ability to perform life
activities.
The subpart H regulations specify that approvals based upon
surrogate endpoints are ``subject to the requirement that the applicant
study the drug further to verify and describe its clinical benefit'' in
postmarketing studies. The postmarketing study requirement for
midodrine HCl was described in the new drug application (NDA)
submission seeking its approval and referenced in the Agency's 1996
approval letter. In the time since PROAMATINE was approved, the NDA
holder has sponsored clinical trials and information regarding the
drug's efficacy has been published, but data submitted to the Agency
have not verified the drug's clinical benefit to FDA's satisfaction.
Accordingly, on August 16, 2010, FDA issued a notice of opportunity for
a hearing (NOOH) on a proposal to withdraw approval of the NDA for
midodrine HCl.
Although the NOOH process is proceeding on a separate track, FDA
recognizes that existing and potential sponsors may wish to conduct the
clinical trials needed to support continued marketing authorization of
midodrine HCl. To assist sponsors in planning and designing such
trials, we are placing in the docket a brief description of a
recommended clinical trial design. We are also inviting interested
parties to submit information to the docket such as any existing
controlled studies that verify the clinical benefit of midodrine HCl
when used to treat orthostatic hypotension. Physicians who treat
orthostatic hypotension and patient organizations that would like to
work with any
[[Page 1621]]
sponsors of new clinical trials are invited to submit correspondence to
the docket identifying themselves. We anticipate that any sponsor
planning to conduct new clinical studies may contact interested
physicians and organizations to solicit information and suitable
volunteer test subjects.
The public docket is available for public review in the Division of
Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: January 6, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-355 Filed 1-10-11; 8:45 am]
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