Proposed Information Collection Activity; Comment Request, 62405-62406 [2010-25023]
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Federal Register / Vol. 75, No. 195 / Friday, October 8, 2010 / Notices
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’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
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Additional Criteria and Procedures for
Classifying OTC Drugs as Generally
Recognized as Safe and Effective and
Not Misbranded—New
In the Federal Register of January 23,
2002 (67 FR 3060), we established
regulations in § 330.14 (21 CFR 330.14)
providing additional criteria and
procedures for classifying OTC drugs as
generally recognized as safe and
effective and not misbranded (2002 TEA
final rule). The regulations in § 330.14
state that OTC drug products introduced
into the U.S. market after the OTC drug
review began and OTC drug products
without any marketing experience in the
United States can be evaluated under
the monograph process if the conditions
(e.g., active ingredients) meet certain
‘‘time and extent’’ criteria outlined in
§ 330.14(b). The regulations allow a
‘‘time and extent’’ application (TEA) to
be submitted to us by any party for our
consideration to include new conditions
in the OTC drug monograph system.
TEAs must provide evidence described
in § 330.14(c) demonstrating that the
condition is eligible for inclusion in the
monograph system. (Section 330.14(d)
specifies the number of copies and
address for submission of a TEA.) If a
condition is found eligible, any
interested parties can submit safety and
effectiveness information as explained
in § 330.14(f). Safety and effectiveness
data include not only the data and
information listed in 21 CFR
330.10(a)(2) (§ 330.14(f)(1)) but also a
listing of all serious adverse drug
experiences that may have occurred
(§ 330.14(f)(2)) as well as an official or
proposed compendial monograph
(§ 330.14(i)).
In the 2002 TEA final rule, we
estimated that 50 TEAs would be
submitted to us annually by
approximately 25 respondents (67 FR
3060 at 3073). We also estimated that
the time required for preparing and
submitting each TEA would be
approximately 480 hours. We continue
to believe that a respondent will spend
approximately 480 hours preparing a
TEA, but we no longer expect to receive
50 TEAs annually. Since 2003, we have
received a total of 16 TEAs from 12
respondents. This is equivalent to 2.3
TEAs annually from 1.7 respondents.
We now estimate that we will receive 2
TEAs annually from 2 respondents (see
table 1 of this document).
We also estimated in the 2002 TEA
final rule that we would receive three
safety and effectiveness submissions for
each condition found eligible for further
consideration under a TEA (67 FR 3060
at 3072). We estimated that we would
receive 90 submissions of safety and
effectiveness data annually. And, we
estimated that it would take
approximately 800 hours to prepare and
submit each safety and effectiveness
submission. We believe that each
submission, including serious adverse
drug experiences and a compendial
monograph, will take approximately 800
hours to complete (see table 1 of this
document). However, we do not believe
the estimated number of submissions is
accurate. During the 8 years that have
elapsed since publication of the 2002
TEA final rule, we have found 14
ingredients eligible under the TEA
process and have received 16
submissions of safety and effectiveness
data from 9 respondents. Therefore, we
now estimate that we will receive two
submissions of safety and effectiveness
data annually from two respondents.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Annual
frequency
per response
Number of
respondents
21 CFR Section
Total annual
responses
Hours per
response
Total hours
330.14(c) and (d) 1 ...............................................................
330.14(f) and (i) 2 .................................................................
2
2
1
1
2
2
480
800
960
1,600
Total ..............................................................................
........................
........................
........................
........................
2,560
1 TEA.
2 Safety
and effectiveness submission, including adverse events and compendial monograph.
Dated: October 3, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–25375 Filed 10–7–10; 8:45 am]
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acknowledgement of paternity. The
affidavit for the voluntary
acknowledgement of paternity must
Administration for Children and
include the minimum requirements
Families
specified by the Secretary under section
452(a)(7) of the Act. The affidavits will
[OMB No. 0970–0171]
be used by hospitals, birth record
agencies, and other entities participating
Proposed Information Collection
in the voluntary paternity establishment
Activity; Comment Request
program, that collect information from
Proposed Projects
parents of children that are born out of
wedlock.
Title: Required Data Elements for
Voluntary Establishment of Paternity
Respondents: Parents of children that
Affidavits.
are born out of wedlock provide the
Description: Section 466(a)(5)(C)(iv) of required information to State and Tribal
the Social Security Act (the Act)
IV–D agencies, hospitals, birth record
requires States to develop and use an
agencies and other entities participating
affidavit for the voluntary
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Federal Register / Vol. 75, No. 195 / Friday, October 8, 2010 / Notices
in the voluntary paternity establishment
program.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
None ................................................................................................................
Estimated Total Annual Burden
Hours: 193,738.
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.
Dated: September 29, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010–25023 Filed 10–7–10; 8:45 am]
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1,167,097
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Plan To Develop a Genetic Testing
Registry at the National Institutes of
Health; Public Meeting; Request for
Comments
AGENCY:
National Institutes of Health,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The National Institutes of
Health is announcing a public meeting
to gather stakeholder perspectives on its
plan to develop the Genetic Testing
Registry. The meeting will provide a
forum for interested stakeholders to
provide comments on specific aspects of
the plan.
Date and Time: The public meeting
will be held November 2, 2010, from 9
a.m. to 12 p.m.
Location: The public meeting will be
held at the Walter E. Johnson
Convention Center, Room 147, 801
Mount Vernon Place, NW., Washington,
DC 20001. For directions, please contact
the Convention Center at 202–249–3000
or refer to the following Web site:
https://www.dcconvention.com/.
Special accommodations: Anyone
planning to attend the meeting who
needs special assistance, such as sign
language interpretation or other
reasonable accommodations, is asked to
contact Cathy Fomous (see Contacts
section) by October 26, 2010.
Registration: If you wish to attend the
public meeting, please register by
October 27, 2010. Registration is free
and on a first-come, first-served basis.
Pre-registration can be completed online
at https://oba.od.nih.gov/gtr/
gtr_meetings.html. Persons without
Internet access may call Ms. Nicole
Numbers at 301–650–8660. Onsite
registration will be based on space
availability.
Requests for Oral Presentations:
Interested persons who would like to
make oral comments during the meeting
will be given 5 minutes to do so if they
submit their request by October 27,
2010, to Cathy Fomous. Send requests
SUMMARY:
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Number of
responses per
respondent
1
Average
burden hours
per response
.166
Total burden
hours
193,738
by e-mail to cfomous@od.nih.gov; by fax
to 301–496–9839; or via postal service
to Cathy Fomous, Ph.D., Office of
Biotechnology Activities, National
Institutes of Health, 6705 Rockledge Dr.,
Suite 750, Bethesda, MD 20892. The
request should include the commenter’s
name, title, affiliation, address, e-mail
address, and telephone number. All
requests should indicate which
questions outlined below in the section
on Public Meeting Focus will be
addressed. Depending on the number of
individuals and organizations that
submit requests to make oral remarks,
the allotted time may be expanded or
shortened to provide all interested
parties an opportunity to present.
Written Comments: Interested persons
who cannot attend the meeting may
submit written comments on the
questions outlined below. Comments
should be submitted to Cathy Fomous
via e-mail, fax, or postal service using
the above contact information. The
comment period for written comments
closes on November 12, 2010.
Contacts: For questions about the
meeting logistics, please contact Ms.
Nicole Numbers at
numbers@palladianpartners.com or
301–650–8660. For special
accommodations or questions about the
meeting agenda and public comments,
please contact Cathy Fomous, Ph.D.,
NIH Office of Biotechnology Activities
at cfomous@od.nih.gov or 301–496–
9838.
SUPPLEMENTARY INFORMATION:
I. Background
Advances in the knowledge of genetic
factors involved in health and disease
have been accompanied by a rapid rise
in the availability of genetic tests,
including those tests that diagnose or
assess the risk for disease, provide
prognostic information, and guide the
selection of drug therapies and dosing.
Although more than 2,000 genetic tests
are available, there is no public resource
that provides centralized information
about the availability and scientific
basis of these tests.
On March 18, 2010, the National
Institutes of Health (NIH) announced its
intent to develop the Genetic Testing
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[Federal Register Volume 75, Number 195 (Friday, October 8, 2010)]
[Notices]
[Pages 62405-62406]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-25023]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
[OMB No. 0970-0171]
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Required Data Elements for Voluntary Establishment of
Paternity Affidavits.
Description: Section 466(a)(5)(C)(iv) of the Social Security Act
(the Act) requires States to develop and use an affidavit for the
voluntary acknowledgement of paternity. The affidavit for the voluntary
acknowledgement of paternity must include the minimum requirements
specified by the Secretary under section 452(a)(7) of the Act. The
affidavits will be used by hospitals, birth record agencies, and other
entities participating in the voluntary paternity establishment
program, that collect information from parents of children that are
born out of wedlock.
Respondents: Parents of children that are born out of wedlock
provide the required information to State and Tribal IV-D agencies,
hospitals, birth record agencies and other entities participating
[[Page 62406]]
in the voluntary paternity establishment program.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average
Instrument Number of responses per burden hours Total burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
None............................................ 1,167,097 1 .166 193,738
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 193,738.
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.
Dated: September 29, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010-25023 Filed 10-7-10; 8:45 am]
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