Proposed Information Collection Activity; Comment Request, 68452-68453 [2013-27221]
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Federal Register / Vol. 78, No. 220 / Thursday, November 14, 2013 / Notices
clearance will provide useful
information, but it will not yield data
that can be generalized to the overall
population. This type of generic
clearance for qualitative information
will not be used for quantitative
information collections that are
designed to yield reliably actionable
results, such as monitoring trends over
time or documenting program
performance. Such data uses require
more rigorous designs that address: the
target population to which
generalization will be made, the
sampling frame, the sample design
(including stratification and clustering),
the precision requirements or power
calculations that justify the proposed
sample size, the expected response rate,
methods for assessing potential nonresponse bias, the protocols for data
collection, and any testing procedures
that were or will be undertaken prior
fielding the study. Depending on the
degree of influence the results are likely
to have, such collections may still be
eligible for submission for other generic
mechanisms that are designed to yield
quantitative results.
The Agency received no comments in
response to the 60-day notice published
in the Federal Register on December 22,
2010 (75 FR 80542).
This is a new collection of
information. Individual respondents can
participate in the telephone survey
voluntary. Below we provide CDC’s
projected annualized estimate for next
three years. There is no cost to
respondents other than their time. The
estimated annualized burden hours for
this data collection activity are 4,000.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of collection
Average
number of
respondents
Annual
frequency per
response
Average
number
of activities
Average hours
per response
Interactive Voice Surveys, Online Surveys .....................................................
60,000
1
1
4/60
Kimberly S. Lane,
Deputy Director, Office of Scientific Integrity,
Office of the Associate Director for Science,
Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2013–27275 Filed 11–13–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: ACF Program Instruction:
Children’s Justice Act.
OMB No.: 0980–0196.
Description: The Program Instruction,
prepared in response to the enactment
of the Childrens Justice Act (CJA), Title
II of Public Law. 111–320, Child Abuse
Prevention and Treatment Act
Reauthorization of 2010, provides
direction to the States and Territories to
accomplish the purposes of assisting
States in developing, establishing and
operating programs designed to
improve: (1) The assessment and
investigation of suspected child abuse
and neglect cases, including cases of
suspected child sexual abuse and
exploitation, in a manner that limits
additional trauma to the child and the
child’s family; (2) the assessment and
investigation of cases of suspected child
abuse-related fatalities and suspected
child neglect-related fatalities; (3) the
investigation and prosecution of cases of
child abuse and neglect, including child
sexual abuse and exploitation; and (4)
the assessment and investigation of
cases involving children with
disabilities or serious health-related
problems who are suspected victims of
child abuse or neglect. This Program
Instruction contains information
collection requirements that are found
in P. L. 111–320 at Sections 107(b) and
107(d), and pursuant to receiving a grant
award. The information being collected
is required by statute to be submitted
pursuant to receiving a grant award. The
information submitted will be used by
the agency to ensure compliance with
the statute; to monitor, evaluate and
measure grantee achievements in
addressing the investigation and
prosecution of child abuse and neglect;
and to report to Congress.
Respondents: State Governments
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Application & Annual Report ...........................................................................
Number of
responses per
respondent
52
1
TKELleY on DSK3SPTVN1PROD with NOTICES
Estimated total annual burden hours .......................................................
In compliance with the requirements
of Section 506(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
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19:20 Nov 13, 2013
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60
Total
burden
hours
3,120
3,120
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email 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
PO 00000
Average
burden hours
per response
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
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Federal Register / Vol. 78, No. 220 / Thursday, November 14, 2013 / Notices
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. 2013–27221 Filed 11–13–13; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1152]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Petition to Request
an Exemption From 100 Percent
Identity Testing of Dietary Ingredients:
Current Good Manufacturing Practice
in Manufacturing, Packaging, Labeling,
or Holding Operations for Dietary
Supplements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (the PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information and to
allow 60 days for public comment in
response to the notice. This notice
invites comments on the information
collection provisions of our existing
regulations governing petitions to
request an exemption from 100 percent
identity testing of dietary ingredients.
DATES: Submit either electronic or
written comments on the collection of
information by January 13, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information 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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
TKELleY on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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19:20 Nov 13, 2013
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Dr., PI50–400B, Rockville, MD 20850,
301–796–3793, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
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.
Petition To Request an Exemption From
100 Percent Identity Testing of Dietary
Ingredients: Current Good
Manufacturing Practice in
Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary
Supplements—21 CFR 111.75(a)(1)(ii)
(OMB Control Number 0910–0608)—
Extension
The Dietary Supplement Health and
Education Act (Pub. L. 103–417) added
section 402(g) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 342(g)), which provides, in part,
that the Secretary of Health and Human
Services (the Secretary) may, by
regulation, prescribe good
manufacturing practices for dietary
supplements. Section 402(g)(1) of the
FD&C Act states that a dietary
supplement is adulterated if ‘‘it has
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68453
been prepared, packed, or held under
conditions that do not meet current
good manufacturing practice
regulations.’’ Section 701(a) of the FD&C
Act (21 U.S.C. 371(a)) gives us the
authority to issue regulations for the
efficient enforcement of the FD&C Act.
Part 111 of our regulations (21 CFR
part 111) establishes the minimum
Current Good Manufacturing Practice
(CGMP) necessary for activities related
to manufacturing, packaging, labeling,
or holding dietary supplements to
ensure the quality of the dietary
supplement. Section 111.75(a)(1) of our
regulations (21 CFR 111.75(a)(1))
establishes a procedure for a petition to
request an exemption from 100 percent
identity testing of dietary ingredients.
According to § 111.75(a)(1)(ii),
manufacturers may request an
exemption from the requirements set
forth in § 111.75(a)(1)(i) when the
dietary ingredient is obtained from one
or more suppliers identified in the
petition. The regulation clarifies that we
are willing to consider, on a case-bycase basis, a manufacturer’s conclusion,
supported by appropriate data and
information in the petition submission,
that it has developed a system that it
would implement as a sound, consistent
means of establishing, with no material
diminution of assurance compared to
the assurance provided by 100 percent
identity testing, the identity of the
dietary ingredient before use.
Section 111.75(a)(1) reflects our
determination that manufacturers that
test or examine 100 percent of the
incoming dietary ingredients for
identity can be assured of the identity
of the ingredient. However, we
recognize that it may be possible for a
manufacturer to demonstrate, through
various methods and processes in use
over time for its particular operation,
that a system of less than 100 percent
identity testing would result in no
material diminution of assurance of the
identity of the dietary ingredient as
compared to the assurance provided by
100 percent identity testing. To provide
an opportunity for a manufacturer to
make such a showing and reduce the
frequency of identity testing of
components that are dietary ingredients
from 100 percent to some lower
frequency, we added to § 111.75(a)(1),
an exemption from the requirement of
100 percent identity testing when a
manufacturer petitions the Agency for
such an exemption to 100 percent
identity testing under 21 CFR 10.30 and
the Agency grants such exemption.
Such a procedure would be consistent
with our stated goal, as described in the
CGMP final rule, of providing flexibility
in the CGMP requirements. Section
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]]>Agencies
[Federal Register Volume 78, Number 220 (Thursday, November 14, 2013)]
[Notices]
[Pages 68452-68453]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27221]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: ACF Program Instruction: Children's Justice Act.
OMB No.: 0980-0196.
Description: The Program Instruction, prepared in response to the
enactment of the Childrens Justice Act (CJA), Title II of Public Law.
111-320, Child Abuse Prevention and Treatment Act Reauthorization of
2010, provides direction to the States and Territories to accomplish
the purposes of assisting States in developing, establishing and
operating programs designed to improve: (1) The assessment and
investigation of suspected child abuse and neglect cases, including
cases of suspected child sexual abuse and exploitation, in a manner
that limits additional trauma to the child and the child's family; (2)
the assessment and investigation of cases of suspected child abuse-
related fatalities and suspected child neglect-related fatalities; (3)
the investigation and prosecution of cases of child abuse and neglect,
including child sexual abuse and exploitation; and (4) the assessment
and investigation of cases involving children with disabilities or
serious health-related problems who are suspected victims of child
abuse or neglect. This Program Instruction contains information
collection requirements that are found in P. L. 111-320 at Sections
107(b) and 107(d), and pursuant to receiving a grant award. The
information being collected is required by statute to be submitted
pursuant to receiving a grant award. The information submitted will be
used by the agency to ensure compliance with the statute; to monitor,
evaluate and measure grantee achievements in addressing the
investigation and prosecution of child abuse and neglect; and to report
to Congress.
Respondents: State Governments
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Application & Annual Report..................... 52 1 60 3,120
---------------------------------------------------------------
Estimated total annual burden hours......... 3,120
----------------------------------------------------------------------------------------------------------------
In compliance with the requirements of Section 506(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
Planning, Research and Evaluation, 370 L'Enfant Promenade SW.,
Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email
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
[[Page 68453]]
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. 2013-27221 Filed 11-13-13; 8:45 am]
BILLING CODE 4184-01-P
