Proposed Information Collection Activity; Comment Request, 43208-43209 [2013-17331]
Download as PDF
<![CDATA[
43208
Federal Register / Vol. 78, No. 139 / Friday, July 19, 2013 / Notices
pharmacists) of the PDMPs in the states
where these projects are taking place.
This evaluation is consistent with
CDC’s strategic goals of improving
surveillance, informing policy, and
improving clinical practice. CDC
believes that the most effective
interventions in combating the
prescription drug overdose epidemic
include those designed to identify and
address high-risk patients at a stage
when their risky behaviors can be most
effectively addressed. Strong yet
accessible PDMPs that promote
proactive patient interventions are a
critical component of this high-risk
focused strategy. By enabling providers
to identify high-risk patients at the point
of care, via improved access to and use
of PDMPs and improved
comprehensiveness of PDMP data,
providers can intervene with patients
and address their high-risk behaviors,
including providing or redirecting
patients to substance abuse treatment as
necessary. Through this evaluation, CDC
will better understand the impact of
PDMP integration and interoperability
in the funded states.
The total annual estimated burden
hours for the planned qualitative
information collection are 235 hours.
Total burden time includes the time to
will be conducted at 39 implementation
sites distributed across all nine PEHRIIE
states (range: 3–8 sites per state).
Interviews will be conducted with three
clinical end users per implementation
site for a total of 117 clinical end user
interviews. Based on pilot testing with
three individuals, each clinical end user
interview will take one hour to
complete. Therefore, 117 clinical end
users at 1 hour each will require 117
hours of interviewee time.
It will take 39 hours of recruiter time
to identify potential clinical end user
interviewees, to collect the contact
information from these clinical end
users, and to disseminate this collected
information to the CDC evaluation time.
The CDC will work with one recruiter
per implementation site to complete
these tasks. Based on the time required
to complete similar tasks during the
planning of the clinical end user pilot
interviews, each recruiter is expected to
spend approximately one hour on these
tasks. Therefore, 39 recruiters spending
one hour each on this information
collection will require 39 hours of
recruiter time.
There are no costs to respondents
other than their time.
conduct interviews with key project
staff/stakeholders and clinical end
users, and the time spent by recruiters
at the PEHRIIE implementation sites to
identify potential clinical end user
interviewees.
It will take 79 hours of interviewee
time to complete all of the key project
staff/stakeholder interviews necessary
for the planned evaluation of the
PEHRIIE program. Interviews will be
conducted with 91 key project staff
members/stakeholders across the nine
PEHRIIE-funded states (range: 6–16
interviews per state) as well as 14 key
project staff/stakeholders representing
five companies working with multiples
states involved in the PEHRIIE program,
for a total of 105 key project staff/
stakeholders interviewees. Based on
pilot testing with three individuals,
each key project staff/stakeholder
interview will take approximately 45
minutes to complete. Therefore, 105 key
project staff/stakeholder interviews at
45 minutes each will require 79 hours
of interviewee time.
It will take 117 hours of interviewee
time to complete all of the clinical end
user interviews necessary for the
planned evaluation of the PEHRIIE
program. Each interviewee will be
interviewed once. End user interviews
ESTIMATED ANNUALIZED BURDEN HOURS
Average burden per response
(in hrs)
Number of respondents
Number of responses per
respondent
105
1
45/60
79
Clinical End Users ............................
Clinical End User Recruiters .............
Key Project Staff/Stakeholders Interview Guide.
Clinical End Users Interview Guide
N/A ...................................................
117
39
1
1
1
1
117
39
Total ...........................................
...........................................................
........................
........................
........................
235
Type of respondents
Form name
Key Project Staff/Stakeholders .........
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2013–17295 Filed 7–18–13; 8:45 am]
BILLING CODE 4163–18–P
emcdonald on DSK67QTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Income Withholding Order/
Notice for Support (IWO).
VerDate Mar<15>2010
15:33 Jul 18, 2013
Jkt 229001
OMB No.: 0970–0154.
Description: Statutory requirements
under subsections 466(a)(1), (a)(8) and
466(b)(6) of the Social Security Act
require the use of the Income
Withholding for Support (IWO) form in
all child support cases. The form must
be used by child support agencies,
courts, tribes, private attorneys and
other entities when ordering or sending
notices to withhold. 42 U.S.C 666(a)(1)
and (8); 42 U.S.C 666(b)(6).
The Income Withholding for Support
(IWO) form previously approved by the
Office of Management and Budget has
been modified to address items
identified by states and employers/
income withholders. The title of the
form is changed to Income Withholding
Order/Notice for Support (IWO) to
correspond to the first line of the form.
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
Total burden
(in hrs)
The blank box for court use is removed
and text shifted to make better use of
available space. Language is inserted to
explain that provisions of the Consumer
Credit Protection Act (CCPA) apply only
to employees and not to independent
contractors. A header with caseidentifying information is added on
Page Two and a Social Security Number
on Page Three to place case-identifying
information on each page and allow
future automated improvements for
employers and states. Clarifications are
added to the Instructions emphasizing
that each IWO should represent the
information for only one case, as
defined in the Code of Federal
Regulations.
Respondents: Not applicable.
E:\FR\FM\19JYN1.SGM
19JYN1
Federal Register / Vol. 78, No. 139 / Friday, July 19, 2013 / Notices
43209
ANNUAL BURDEN ESTIMATES
Reporting
requirement
Number of
respondents
Employers .........................................................
Non-IV–D CPs ..................................................
e IWO Employers ..............................................
Total ...........................................................
Estimated Total Annual Burden
Hours: 521,449
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
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. 2013–17331 Filed 7–18–13; 8:45 am]
BILLING CODE 4184–01–P
emcdonald on DSK67QTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0815]
Narcolepsy Public Meeting on PatientFocused Drug Development
AGENCY:
Food and Drug Administration,
HHS.
VerDate Mar<15>2010
15:33 Jul 18, 2013
Jkt 229001
1,283,965
2,436,312
4,763
3,721,508
Number of
responses per
respondent
7.44
1.00
131.75
............................
Annual number
of responses
9,552,699.60
2,436,312.00
627,525.25
12,052,319
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public meeting and an opportunity for
public comment on Patient-Focused
Drug Development for narcolepsy.
Patient-Focused Drug Development is
part of FDA’s performance
commitments in the fifth authorization
of the Prescription Drug User Fee Act
(PDUFA V). The public meeting is
intended to allow FDA to obtain
patients’ perspectives on the impact of
narcolepsy on daily life as well as the
available therapies for narcolepsy.
DATES: The public meeting will be held
on September 24, 2013, from 1 p.m. to
5 p.m. Registration to attend the meeting
must be received by September 13,
2013. See the SUPPLEMENTARY
INFORMATION section for information on
how to register for the meeting. Submit
electronic or written comments by
November 25, 2013.
ADDRESSES: The meeting will be held at
the FDA White Oak Campus, 10903
New Hampshire Ave., Building 31
Conference Center, Section A of the
Great Room (Rm. 1503), Silver Spring,
MD 20993. Entrance for the public
meeting participants is through Building
1, where routine security check
procedures will be performed. For more
information on parking and security
procedures, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
Submit electronic comments to
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.
FDA will post the agenda
approximately 5 days before the meeting
at: https://www.fda.gov/ForIndustry/
UserFees/PrescriptionDrugUserFee/
ucm359018.htm.
FOR FURTHER INFORMATION CONTACT:
Pujita Vaidya, Center for Drug
SUMMARY:
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
Average burden
hours per
response
2 minutes ..........
5 minutes ..........
3 seconds .........
...........................
Total burden
hours
318,423
203,026
523
521,449
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1170,
Silver Spring, MD 20993, 301–796–
0684, FAX: 301–847–8443, email:
Pujita.Vaidya@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background on Patient-Focused Drug
Development
FDA has selected narcolepsy to be the
focus of a meeting under PatientFocused Drug Development, an
initiative that involves obtaining a better
understanding of patients’ perspectives
on the severity of the disease and the
available therapies for the condition.
Patient-Focused Drug Development is
being conducted to fulfill FDA’s
performance commitments made as part
of the authorization of PDUFA under
Title I of the Food and Drug Safety and
Innovation Act (FDASIA) (Pub. L. 112–
144). The full set of performance
commitments is available on the FDA
Web site at https://www.fda.gov/
downloads/forindustry/userfees/
prescriptiondruguserfee/
ucm270412.pdf.
FDA has committed to obtain the
patient perspective in 20 disease areas
during the course of PDUFA V. For each
disease area, the Agency will conduct a
public meeting to discuss the disease
and its impact on patients’ daily lives,
the types of treatment benefit that
matter most to patients, and patients’
perspectives on the adequacy of the
available therapies. These meetings will
include participation of FDA review
divisions, the relevant patient
community, and other interested
stakeholders.
On April 11, 2013, FDA published a
notice in the Federal Register (78 FR
22613) announcing the disease areas for
meetings in fiscal years (FY) 2013–2015,
the first 3 years of the 5-year PDUFA V
timeframe. To develop the list of disease
areas, the Agency used several criteria
that were outlined in the April 11
notice. The Agency gathered public
comment on these criteria and potential
disease areas through a notice for public
comment published in the Federal
Register on September 24, 2012 (77 FR
55849), and through a public meeting
E:\FR\FM\19JYN1.SGM
19JYN1
]]>Agencies
[Federal Register Volume 78, Number 139 (Friday, July 19, 2013)]
[Notices]
[Pages 43208-43209]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17331]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Income Withholding Order/Notice for Support (IWO).
OMB No.: 0970-0154.
Description: Statutory requirements under subsections 466(a)(1),
(a)(8) and 466(b)(6) of the Social Security Act require the use of the
Income Withholding for Support (IWO) form in all child support cases.
The form must be used by child support agencies, courts, tribes,
private attorneys and other entities when ordering or sending notices
to withhold. 42 U.S.C 666(a)(1) and (8); 42 U.S.C 666(b)(6).
The Income Withholding for Support (IWO) form previously approved
by the Office of Management and Budget has been modified to address
items identified by states and employers/income withholders. The title
of the form is changed to Income Withholding Order/Notice for Support
(IWO) to correspond to the first line of the form. The blank box for
court use is removed and text shifted to make better use of available
space. Language is inserted to explain that provisions of the Consumer
Credit Protection Act (CCPA) apply only to employees and not to
independent contractors. A header with case-identifying information is
added on Page Two and a Social Security Number on Page Three to place
case-identifying information on each page and allow future automated
improvements for employers and states. Clarifications are added to the
Instructions emphasizing that each IWO should represent the information
for only one case, as defined in the Code of Federal Regulations.
Respondents: Not applicable.
[[Page 43209]]
Annual Burden Estimates
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Reporting requirement Number of responses per Annual number of Average burden hours per response Total burden
respondents respondent responses hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Employers.................................. 1,283,965 7.44 9,552,699.60 2 minutes.......................... 318,423
Non-IV-D CPs............................... 2,436,312 1.00 2,436,312.00 5 minutes.......................... 203,026
e IWO Employers............................ 4,763 131.75 627,525.25 3 seconds.......................... 523
Total.................................. 3,721,508 ................ 12,052,319 ................................... 521,449
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 521,449
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 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. 2013-17331 Filed 7-18-13; 8:45 am]
BILLING CODE 4184-01-P
