Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submission Process for Voluntary Complaints to the Center for Devices and Radiological Health, 26373-26374 [2013-10597]
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26373
Federal Register / Vol. 78, No. 87 / Monday, May 6, 2013 / Notices
ANNUAL RESPONSE BURDEN ESTIMATES
[This information collection request is for a two-year period.]
Total number
of respondents
Instrument
No. of responses per
respondent
Average burden hours per
response
Total burden
hours
Annual burden
hours
Previously Approved Instruments
PRS ......................................................................................
HPOG-Impact Baseline Survey(s) (Supplemental baseline
questions; study sample members) .................................
HPOG-Impact Baseline Survey(s) (Supplemental baseline
questions; grantees) .........................................................
32
4
31.2
3,994
1,997
10,500
1
0.25
2,625
1,313
20
525
0.25
2,625
1,313
54
1
2
108
54
162
54
1
1
0.17
4
28
216
14
108
60
1
0.50
30
15
60
1
0.75
45
22
20
1
1.50
30
15
80
540
500
200
5,600
1
1
1
1
1
1
0.5
0.5
0.5
0.7
80
270
250
100
3,920
40
135
125
50
1,960
2,800
600
1
1
0.6
0.7
1,680
420
840
210
Current Request for Approval
HPOG–NIE Sampling Questionnaire for the HPOG surveys ..................................................................................
HPOG–NIE Follow-Up Phone Call Protocol for the
Stakholder/Network survey ..............................................
HPOG–NIE Grantee survey .................................................
HPOG-Impact Implementation interview guide for
partnering employers ........................................................
HPOG-Impact Implementation interview guide for instructors ....................................................................................
HPOG-Impact Implementation interview guide for HPOG
program mangement ........................................................
HPOG-Impact Implementation interview guide for HPOG
program staff ....................................................................
HPOG–NIE Management and Staff survey .........................
HPOG–NIE Stakeholder/Network survey ............................
HPOG–NIE Employer survey ..............................................
HPOG-Impact 15-month Participant Follow-Up survey .......
HPOG-Impact 15-month Control Group Member Follow-Up
survey ...............................................................................
HPOG–NIE 15-month Participant Follow-Up survey ...........
mstockstill on DSK4VPTVN1PROD with NOTICES
Estimated Annual Response Burden Hours: 8,211.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: OPRE Reports
Clearance Officer. All requests should
be identified by the title of the
information collection. Email address:
OPREinfocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of the information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collections
should be sent directly to the following:
Office of Management and Budget,
Paperwork Reduction Project, Email:
OIRA_
OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the
VerDate Mar<15>2010
17:06 May 03, 2013
Jkt 229001
Administration for Children and
Families.
Steven M. Hanmer,
OPRE Reports Clearance Officer.
[FR Doc. 2013–10577 Filed 5–3–13; 8:45 am]
BILLING CODE 4184–09–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0485]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Electronic
Submission Process for Voluntary
Complaints to the Center for Devices
and Radiological Health
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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
SUMMARY:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
information voluntarily submitted to the
Center for Devices and Radiological
Health (CDRH) on actual or potential
health risk concerns about a medical
device or radiological product or its use.
Submit either electronic or
written comments on the collection of
information by July 5, 2013.
DATES:
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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
E:\FR\FM\06MYN1.SGM
06MYN1
26374
Federal Register / Vol. 78, No. 87 / Monday, May 6, 2013 / Notices
400B, Rockville, MD 20850, 301–796–
5156, daniel.gittleson@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
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.
Electronic Submission Process for
Voluntary Complaints to the Center for
Devices and Radiological Health—
(OMB Control Number 0910–NEW)
This ICR collects information
voluntarily submitted to the Center for
Devices and Radiological Health (CDRH)
on actual or potential health risk
concerns about a medical device or
radiological product or its use. Because
there has been no established guidelines
or instructions on how to submit a
compliant to CDRH, complaints often
contain minimal information and are
received via phone calls, emails, or
conversationally from any CDRH staff.
CDRH seeks to establish a consistent
format and process for the submission of
device complaints that will enhance our
timeliness in receiving, assessing and
evaluating voluntary complaints. The
information provided in the complaints
received by CDRH may be used to
clarify the recurrence or emergence of
significant device-related risks to the
general public and the need to initiate
educational outreach or regulatory
action to minimize or mitigate identified
risks.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
respondents
1
Total annual
responses
Average
burden per
response
Total hours
1
700
.25 (15
minutes)
125
There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–10597 Filed 5–3–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0418]
An Evaluation of the Prescription Drug
User Fee Act Workload Adjuster;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on an
assessment of the Prescription Drug
User Fee Act (PDUFA) Workload
Adjuster conducted by an independent
consulting firm. This assessment was
conducted to fulfill FDA performance
commitments made as part of the fifth
authorization of PDUFA in section XV,
SUMMARY:
mstockstill on DSK4VPTVN1PROD with NOTICES
Number of
responses per
respondent
700
Activity
VerDate Mar<15>2010
17:53 May 03, 2013
Jkt 229001
‘‘Improving FDA Performance
Management,’’ subsection B, which was
reauthorized by the Food and Drug
Administration Safety and Innovation
Act (FDASIA) of 2012. The assessment
will be conducted by an independent
consultant in two phases. This is the
first assessment of two during PDUFA V
to evaluate whether the adjustment
reasonably represents actual changes in
workload volume and complexity in the
human drug review program and
present options to discontinue, retain,
or modify any elements of the
adjustment. After review of the report
and receipt of public comment, FDA can
adopt appropriate change to the
workload adjustment methodology, if
warranted.
DATES: Submit electronic or written
comments by June 5, 2013.
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.
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FOR FURTHER INFORMATION CONTACT:
Giles Mills, Office of Planning, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 3288,
Silver Spring, MD 20993–0002, 301–
796–4707, Giles.Mills@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2012, the President signed
into law FDASIA. This new law
includes the reauthorization of PDUFA
that provides FDA with the necessary
resources to maintain a predictable and
efficient review process for human drug
and biologic products.
Title I of FDASIA is the fifth
authorization of PDUFA and includes
by reference the performance goals and
procedures for PDUFA V transmitted by
the Secretary of Health and Human
Services to Congress in a commitment
letter. FDA developed recommendations
for PDUFA V in consultation with drug
industry representatives, patient and
consumer advocates, healthcare
professionals, and other public
stakeholders from July 2010 through
May 2011. These recommendations
included an FDA commitment to
contract with an independent
E:\FR\FM\06MYN1.SGM
06MYN1
]]>Agencies
[Federal Register Volume 78, Number 87 (Monday, May 6, 2013)]
[Notices]
[Pages 26373-26374]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10597]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0485]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Electronic Submission Process for Voluntary Complaints
to the Center for Devices and Radiological Health
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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 and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information voluntarily submitted to the
Center for Devices and Radiological Health (CDRH) on actual or
potential health risk concerns about a medical device or radiological
product or its use.
DATES: Submit either electronic or written comments on the collection
of information by July 5, 2013.
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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-
[[Page 26374]]
400B, Rockville, MD 20850, 301-796-5156, daniel.gittleson@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 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.
Electronic Submission Process for Voluntary Complaints to the Center
for Devices and Radiological Health--(OMB Control Number 0910-NEW)
This ICR collects information voluntarily submitted to the Center
for Devices and Radiological Health (CDRH) on actual or potential
health risk concerns about a medical device or radiological product or
its use. Because there has been no established guidelines or
instructions on how to submit a compliant to CDRH, complaints often
contain minimal information and are received via phone calls, emails,
or conversationally from any CDRH staff. CDRH seeks to establish a
consistent format and process for the submission of device complaints
that will enhance our timeliness in receiving, assessing and evaluating
voluntary complaints. The information provided in the complaints
received by CDRH may be used to clarify the recurrence or emergence of
significant device-related risks to the general public and the need to
initiate educational outreach or regulatory action to minimize or
mitigate identified risks.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
700 1 700 .25 (15 125
minutes)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-10597 Filed 5-3-13; 8:45 am]
BILLING CODE 4160-01-P
