Agency Forms Undergoing Paperwork Reduction Act Review, 62412-62413 [2011-26008]
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Federal Register / Vol. 76, No. 195 / Friday, October 7, 2011 / Notices
EXHIBIT 3—ESTIMATED TOTAL AND
ANNUAL COST—Continued
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Annual
cost
Centers for Disease Control and
Prevention
Cost component
Coordination .........
Stakeholder Feedback ...................
Technical Expert
Panel .................
Evaluation Design
& Implementation ....................
Technical Assistance Plan ..........
Data Collection Instruments ..........
OMB Clearance ....
Section 508 Compliance ...............
Data and Analysis
Reports ..............
Interim Evaluation
Reports ..............
Dissemination .......
Final Report ..........
Total ...............
Total cost
38,003
7,601
201,637
40,327
359,276
71,855
3,981,390
934,440
138,997
35,617
13,883
735,426
408,803
736,149
103,269
8,258,311
103,269
1,651,662
jlentini on DSK4TPTVN1PROD with NOTICES
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ healthcare
research and healthcare information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: September 26, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011–25691 Filed 10–6–11; 8:45 am]
BILLING CODE 4160–90–M
16:33 Oct 06, 2011
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
796,278 review by the Office of Management and
Budget (OMB) in compliance with the
186,888
Paperwork Reduction Act (44 U.S.C.
27,799 chapter 35). To request a copy of these
17,808 requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an e2,777 mail to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
147,085 Management and Budget, Washington,
DC 20503 or by fax to (202) 395–5806.
81,761 Written comments should be received
184,037 within 30 days of this notice.
Request for Comments
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Proposed Project
Possession, Use, and Transfer of
Select Agents and Toxins (OMB)
Control No. (0920–0576) Exp. 12/31/
2011—Revision—Office of Public
Health Preparedness and Response
(OPHPR), Division of Select Agents and
Toxins (DSAT), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002, Subtitle A of
Public Law 107–188 (42 U.S.C. 262a),
requires the United States Department
of Health and Human Services (HHS) to
regulate the possession, use, and
transfer of biological agents or toxins
(i.e., select agents and toxins) that could
pose a severe threat to public health and
safety. The Agricultural Bioterrorism
Protection Act of 2002, Subtitle B of
Public Law 107–188 (7 U.S.C. 8401),
requires the United States Department
of Agriculture (USDA) to regulate the
possession, use, and transfer of
biological agents or toxins (i.e., select
agents and toxins) that could pose a
severe threat to animal or plant health,
or animal or plant products. In
accordance with these Acts, HHS and
USDA promulgated regulations
requiring entities to register with the
CDC or the Animal and Plant Health
Inspection Service (APHIS) if they
possess, use, or transfer a select agent or
toxin (42 CFR part 73, 7 CFR part 331,
and 9 CFR part 121).
CDC is requesting continued OMB
approval to collect this information
through the use of five forms: (1)
Application for Registration, (2) Request
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to Transfer Select Agent or Toxin, (3)
Report of Theft, Loss, or Release of
Select Agent and Toxin, (4) Report of
Identification of Select Agent or Toxin,
and (5) Request for Exemption. Revision
will be made to (2) Request to Transfer
Select Agent or Toxin, (3) Report of
Theft, Loss, or Release of Select Agent
and Toxin, (4) Report of Identification of
Select Agent or Toxin. There will be no
revisions made to the Application for
Registration and Request for Exemption
The total estimated annualized burden
for all data collection is 8,878 hours.
Information will be collected via fax, email and mail from respondents of the
320 entities registered with the Select
Agent Program. Annualized burden
hours were calculated by multiplying
the average number of hours used to
complete the: (1) Application for
Registration; (2) Request to Transfer
Select Agent or Toxin; (3) Report of
Theft, Loss, or Release of Select Agent
or Toxin; (4) Report of Identification of
Select Agent or Toxin; and (5) Request
for Exemption. The estimated
annualized burden for the 2008
Possession, Use, and Transfer of Select
Agents and Toxins submission was
9,656.5 hours. The 2011 estimated
annualized burden hours are 8,878.
Burden has been reduced by 778.5
hours due to the removal of similar
questions on the Request to Transfer
Select Agent or Toxin (Form 2), Report
of Theft, Loss, or Release of Select Agent
or Toxin (Form 3) and the Report of
Identification of Select Agent or Toxin
(Form 4). Therefore respondents are not
required to answer as many questions as
requested in the previous data
collection tool.
The Request to Transfer Select Agent
or Toxin form (42 CFR 73.16) will be
used by entities requesting transfer of a
select agent or toxin to their facility.
CDC in conjunction with APHIS has
revised the Request to Transfer Select
Agent or Toxin form by requiring the
recipient to submit the initial request,
be notified by the sender of the expected
shipment date, and verify if the
shipment did not occur. Estimated
average time to complete this form is 1
hour, 30 minutes. Based on data
regarding the transfer requests received
since the last submission, CDC estimates
1 transfer requests submitted per
registered entity on an annual basis.
The Report of Theft, Loss, or Release
of Select Agent and Toxin form (42 CFR
73.19(a)(b)) must be completed by
entities whenever there is theft, loss, or
release of a select agent or toxin.
Estimated average time to complete this
form is 1 hour. Based on data regarding
the reports received since the last
submission, CDC estimates that 1 report
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Federal Register / Vol. 76, No. 195 / Friday, October 7, 2011 / Notices
per respondent will be received on an
annual basis.
The Report of Identification of Select
Agent or Toxin form 42 CFR 73.5(a)(b)
and 73.6(a)(b)) will be used by clinical
and diagnostic laboratories to notify
CDC that select agents or toxins
identified as the result of diagnostic or
proficiency testing have been disposed
of in a proper manner. In addition, the
form will be used by Federal law
complete this form is 1 hour. Based on
data regarding the reports received since
the last submission, CDC estimates that
9 reports per respondent will be
received on an annual basis.
There is no cost to the respondents
other than their time. The total
estimated annualized burden hours are
8,878, which is a reduction of 778.5
hours from the previously approved
ICR.
enforcement agencies to report the
seizure and final disposition of select
agents and toxins. CDC in conjunction
with APHIS has revised the Report of
Identification of Select Agent or Toxin
form to ensure duplicate reports are not
submitted by requesting the entity
making the final identification report
the select agents or toxins identified as
the result of diagnostic or verification
testing. Estimated average time to
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
CFR
Form name
73.3(d) ...................................
73.7(h)(1) ...............................
73.16 ......................................
73.19(a)(b) .............................
73.5 & 73.6(a)(b) ...................
73.5 & 73.6(d–e) ....................
73.3 & 73.4(e)(1) ...................
73.10(e) .................................
73.20 ......................................
73.18 ......................................
Application for Registration ...................................................
Amendment to Registration Application ................................
Request to Transfer Select Agents or Toxins .......................
Notification of Theft, Loss or Release ...................................
Report of Identification of Select Agent ................................
Request of Exemption ...........................................................
Request for Exclusions/Restricted ........................................
Request for Expedited Review ..............................................
Administrative Review ...........................................................
Inspections .............................................................................
Dated: September 30, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2011–26008 Filed 10–6–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10268 and CMS–
1696]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
jlentini on DSK4TPTVN1PROD with NOTICES
AGENCY:
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be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Consolidated
Renal Operations in a Web Enabled
Network (CROWNWeb) Third-party
Submission Authorization Form; Use:
The Consolidated Renal Operations in a
Web Enabled Network (CROWNWeb)
Third-Party Submission Authorization
form is to be completed by ‘‘Facility
Administrators’’ (administrators of
CMS-certified dialysis facilities) if they
intend to authorize a third party (a
business with which the facility is
associated, or an independent vendor)
to submit data to CMS to comply with
the recently-revised Conditions for
Coverage of dialysis facilities. The
CROWNWeb system is the system used
as the collection point of data necessary
for entitlement of ESRD patients to
Medicare benefits and for Federal
Government monitoring and assessing
of the quality and types of care provided
to renal patients. The information
collected through the CWTPSA form
will allow CMS and its contractors to
receive data from authorized parties
acting on behalf of CMS-certified
dialysis facilities. Since February 2009,
CMS has received 4,160 CWTPSA forms
and anticipates that they will continue
to receive no more than 400 new
CWTPSA forms annually to address the
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5
320
320
180
320
3
71
1
30
320
Number responses per
respondent
Average burden
per response
1
8
1
1
9
1
1
1
1
1
4.5
1
1.5
1
1
1
1
1
4
8
creation of new facilities under the
current participating ‘‘third party
submitters.’’ Form Number: CMS–10268
(OCN: 0938–1052); Frequency:
Occasionally; Affected Public: Private
Sector; Business or other for-profits and
Not-for-profit institutions; Number of
Respondents: 400; Total Annual
Responses: 400; Total Annual Hours:
34. (For policy questions regarding this
collection contact Michelle Tucker at
410–786–0736. For all other issues call
410–786–1326.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Appointment of
Representative; Use: This information
collection requests re-approval of an
information collection associated with
regulations that permit individuals or
entities to appoint representatives to
exercise their rights to appeal an initial
determination. The Appointment of
Representative form will be completed
by beneficiaries, providers and
suppliers who wish to appoint
representatives to assist them with
obtaining initial determinations and
filing appeals. The appointment of
representative form must be signed by
the party making the appointment and
the individual agreeing to accept the
appointment. Form Number: CMS–1696
(OCN: 0938–0950); Frequency:
Occasionally; Affected Public:
Individuals or households and Business
or other for-profits; Number of
Respondents: 265,481; Total Annual
Responses: 265,481; Total Annual
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]]>Agencies
[Federal Register Volume 76, Number 195 (Friday, October 7, 2011)]
[Notices]
[Pages 62412-62413]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26008]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-11-0576]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. chapter 35). To request a copy of these requests, call
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail
to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC 20503 or by fax to (202) 395-
5806. Written comments should be received within 30 days of this
notice.
Proposed Project
Possession, Use, and Transfer of Select Agents and Toxins (OMB)
Control No. (0920-0576) Exp. 12/31/2011--Revision--Office of Public
Health Preparedness and Response (OPHPR), Division of Select Agents and
Toxins (DSAT), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002, Subtitle A of Public Law 107-188 (42 U.S.C.
262a), requires the United States Department of Health and Human
Services (HHS) to regulate the possession, use, and transfer of
biological agents or toxins (i.e., select agents and toxins) that could
pose a severe threat to public health and safety. The Agricultural
Bioterrorism Protection Act of 2002, Subtitle B of Public Law 107-188
(7 U.S.C. 8401), requires the United States Department of Agriculture
(USDA) to regulate the possession, use, and transfer of biological
agents or toxins (i.e., select agents and toxins) that could pose a
severe threat to animal or plant health, or animal or plant products.
In accordance with these Acts, HHS and USDA promulgated regulations
requiring entities to register with the CDC or the Animal and Plant
Health Inspection Service (APHIS) if they possess, use, or transfer a
select agent or toxin (42 CFR part 73, 7 CFR part 331, and 9 CFR part
121).
CDC is requesting continued OMB approval to collect this
information through the use of five forms: (1) Application for
Registration, (2) Request to Transfer Select Agent or Toxin, (3) Report
of Theft, Loss, or Release of Select Agent and Toxin, (4) Report of
Identification of Select Agent or Toxin, and (5) Request for Exemption.
Revision will be made to (2) Request to Transfer Select Agent or Toxin,
(3) Report of Theft, Loss, or Release of Select Agent and Toxin, (4)
Report of Identification of Select Agent or Toxin. There will be no
revisions made to the Application for Registration and Request for
Exemption The total estimated annualized burden for all data collection
is 8,878 hours. Information will be collected via fax, e-mail and mail
from respondents of the 320 entities registered with the Select Agent
Program. Annualized burden hours were calculated by multiplying the
average number of hours used to complete the: (1) Application for
Registration; (2) Request to Transfer Select Agent or Toxin; (3) Report
of Theft, Loss, or Release of Select Agent or Toxin; (4) Report of
Identification of Select Agent or Toxin; and (5) Request for Exemption.
The estimated annualized burden for the 2008 Possession, Use, and
Transfer of Select Agents and Toxins submission was 9,656.5 hours. The
2011 estimated annualized burden hours are 8,878. Burden has been
reduced by 778.5 hours due to the removal of similar questions on the
Request to Transfer Select Agent or Toxin (Form 2), Report of Theft,
Loss, or Release of Select Agent or Toxin (Form 3) and the Report of
Identification of Select Agent or Toxin (Form 4). Therefore respondents
are not required to answer as many questions as requested in the
previous data collection tool.
The Request to Transfer Select Agent or Toxin form (42 CFR 73.16)
will be used by entities requesting transfer of a select agent or toxin
to their facility. CDC in conjunction with APHIS has revised the
Request to Transfer Select Agent or Toxin form by requiring the
recipient to submit the initial request, be notified by the sender of
the expected shipment date, and verify if the shipment did not occur.
Estimated average time to complete this form is 1 hour, 30 minutes.
Based on data regarding the transfer requests received since the last
submission, CDC estimates 1 transfer requests submitted per registered
entity on an annual basis.
The Report of Theft, Loss, or Release of Select Agent and Toxin
form (42 CFR 73.19(a)(b)) must be completed by entities whenever there
is theft, loss, or release of a select agent or toxin. Estimated
average time to complete this form is 1 hour. Based on data regarding
the reports received since the last submission, CDC estimates that 1
report
[[Page 62413]]
per respondent will be received on an annual basis.
The Report of Identification of Select Agent or Toxin form 42 CFR
73.5(a)(b) and 73.6(a)(b)) will be used by clinical and diagnostic
laboratories to notify CDC that select agents or toxins identified as
the result of diagnostic or proficiency testing have been disposed of
in a proper manner. In addition, the form will be used by Federal law
enforcement agencies to report the seizure and final disposition of
select agents and toxins. CDC in conjunction with APHIS has revised the
Report of Identification of Select Agent or Toxin form to ensure
duplicate reports are not submitted by requesting the entity making the
final identification report the select agents or toxins identified as
the result of diagnostic or verification testing. Estimated average
time to complete this form is 1 hour. Based on data regarding the
reports received since the last submission, CDC estimates that 9
reports per respondent will be received on an annual basis.
There is no cost to the respondents other than their time. The
total estimated annualized burden hours are 8,878, which is a reduction
of 778.5 hours from the previously approved ICR.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number
CFR Form name Number of responses per Average burden
respondents respondent per response
----------------------------------------------------------------------------------------------------------------
73.3(d)............................ Application for 5 1 4.5
Registration.
73.7(h)(1)......................... Amendment to Registration 320 8 1
Application.
73.16.............................. Request to Transfer Select 320 1 1.5
Agents or Toxins.
73.19(a)(b)........................ Notification of Theft, 180 1 1
Loss or Release.
73.5 & 73.6(a)(b).................. Report of Identification 320 9 1
of Select Agent.
73.5 & 73.6(d-e)................... Request of Exemption...... 3 1 1
73.3 & 73.4(e)(1).................. Request for Exclusions/ 71 1 1
Restricted.
73.10(e)........................... Request for Expedited 1 1 1
Review.
73.20.............................. Administrative Review..... 30 1 4
73.18.............................. Inspections............... 320 1 8
----------------------------------------------------------------------------------------------------------------
Dated: September 30, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-26008 Filed 10-6-11; 8:45 am]
BILLING CODE 4163-18-P
