Agency Forms Undergoing Paperwork Reduction Act Review, 3851-3852 [E6-808]
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Federal Register / Vol. 71, No. 15 / Tuesday, January 24, 2006 / Notices
2. Name of Subcommittee: Health
Research Dissemination and
Implementation.
Date: February 16, 2006 (Open from 8
a.m. to 8:15 a.m. on February 16
and closed for remainder of the
meeting).
3. Name of Subcommittee: Health Care
Quality and Effectiveness Research.
Date: February 23, 2006 (Open from 8
a.m. to 8:15 a.m. on February 23
and closed for remainder of the
meeting).
4. Name of Subcommittee: Health
Research Training.
Date: February 27–28, 2006 (Open
from 9 a.m. to 9:15 a.m. on February
27 and closed for remainder of the
meeting).
5. Name of Subcommittee: Health
Systems Research.
Date: February 28, 2006 (Open from 9
a.m. to 9:15 a.m. on February 28
and closed for remainder of the
meeting).
All the meetings above will take place
at: Agency for Healthcare Research and
Quality, John Eisenberg Conference
Center, 540 Gaither Road, Rockville,
Maryland 20850.
Contact Person: Anyone wishing to
obtain a roster of members, agenda or
minutes of the nonconfidential portions
of the meetings should contact Mrs.
Bonnie Campbell, Committee
Management Officer, Office of
Extramural Research, Education and
Priority Populations, AHRQ, 540
Gaither Road, Suite 2000, Rockville,
Maryland 20850, Telephone (301) 427–
1554.
Agenda items for these meetings are
subject to change as priorities dictate.
This notice is being published less
than 15 days prior to the February 2
meeting, due to the time constraints of
reviews and funding cycles.
Dated: January 13, 2006.
Carolyn M. Clancy,
Director.
[FR Doc. 06–611 Filed 1–23–06; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
rmajette on PROD1PC67 with NOTICES1
[30Day–06–0576]
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
VerDate Aug<31>2005
14:44 Jan 23, 2006
Jkt 208001
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) 639–4766 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–6974. 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)—Revision—Office of
the Director (OD), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (Pub. L. 107–188)
specifies that the Secretary of Health
and Human Services (HHS) shall
provide for the establishment and
enforcement of standards and
procedures governing the possession,
use, and transfer of select agents and
toxins that have the potential to pose a
severe threat to public health and safety.
The Act specifies that entities that
possess, use, and transfer these select
agents register with the HHS Secretary.
The HHS Secretary has designated CDC
as the agency responsible for collecting
this information.
CDC is requesting continued OMB
approval to collect this information
through the use of five separate forms.
These forms are: (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.
The Application for Registration (42
CFR, 73.7(d)) is used by entities to
register with CDC. The Application for
Registration requests facility
information; a list of select agents or
toxins in use, possession, or for transfer
by the entity; characterization of the
select agent or toxin; and laboratory
information. Estimated average time to
complete this form is 3 hours, 45
minutes for an entity with one principal
investigator working with one select
agent or toxin. CDC estimates that
entities will need an additional 45
minutes for each additional investigator
or agent. In our regulatory analysis, we
have estimated that 70% of the 350
entities have 1–3 principal investigators,
15% have 5 principal investigators, and
15% have 10 principal investigators. We
have used these figures to calculate the
burden for this section. Estimated
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3851
burden for the Application for
Registration is 2,191 hours.
Entities may amend their registration
(42 CFR, 73.7(h)(1)) if any changes occur
in the information submitted to CDC. To
apply for an amendment to a certificate
of registration, an entity must obtain the
relevant portion of the application
package and submit the information
requested in the package to CDC.
Estimated time to amend a registration
package is 1 hour.
The Request to Transfer Select Agent
or Toxin form (42 CFR 73.16) is used by
entities requesting transfer of a select
agent or toxin to their facility and by the
entity transferring the agent. CDC
revised the Request to Transfer Select
Agent or Toxin form by removing the
requirement that entities provide
written notice within five business days
when select agents or toxins are
consumed or destroyed after a transfer.
Estimated average time to complete this
form is 1 hour, 30 minutes.
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.
The Report of Identification of Select
Agent or Toxin form 42 CFR 73.5(a)(b)
and 73.6(a)(b)) is 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 is
used by Federal law enforcement
agencies to report the seizure and final
disposition of select agents and toxins.
Estimated average time to complete this
form is 1 hour.
The Request for Exemption form (42
CFR 73.5 (d)(e) and 73.6 (d)(e)) is used
by entities that are using an
investigational product that are, bear, or
contain select agents or toxins or in
cases of public health emergency.
Estimated average time to complete this
form is 1 hour.
In addition to the standardized forms,
this regulation also outlines situations
in which an entity must notify or may
make a request of the HHS Secretary in
writing. An entity may apply to the HHS
Secretary for an expedited review of an
individual by the Attorney General (42
CFR 73.10(e)). To apply for this
expedited review, an entity must submit
a request in writing to the HHS
Secretary establishing the need for such
action. The estimated time to gather the
information and submit this request is
30 minutes. CDC has not developed
standardized forms to use in the above
situations. Rather, the entity should
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Federal Register / Vol. 71, No. 15 / Tuesday, January 24, 2006 / Notices
provide the information as requested in
the appropriate section of the
regulation.
An entity may also apply to the HHS
Secretary for an exclusion of an
attenuated strain of a select agent or
toxin that does not pose a severe threat
to public health and safety (42 CFR
73.3(e)(1) and 73.4(e)(1)). The estimated
time to gather the information and
submit this request is 1 hour.
As part of the requirements of the
Responsible Official, the Responsible
Official is required to conduct regular
inspections (at least annually) of the
laboratory where select agents or toxins
are stored. Results of these selfinspections must be documented (42
CFR 73.9(a)(5)). CDC estimates, that, on
average, such documentation will take 1
hour.
As part of the training requirements of
this regulation, the entity is required to
record the identity of the individual
trained, the date of training, and the
means used to verify that the employee
understood the training (42 CFR
73.15(c)). Estimated time for this
documentation is 2 hours per principal
investigator.
An individual or entity may request
administrative review of a decision
denying or revoking certification of
registration or an individual may appeal
a denial of access approval (42 CFR
73.20). This request must be made in
writing and within 30 calendar days
after the adverse decision. This request
should include a statement of the
factual basis for the review. CDC
estimates the time to prepare and
submit such a request is 4 hours.
Finally, an entity must implement a
system to ensure that certain records
and databases are accurate and that the
authenticity of records may be verified
(42 CFR 73.17(b)). The time to
implement such a system is estimated to
average 4 hours.
The cost to respondents is their time
to complete the forms and comply with
the reporting and recordkeeping
components of the Act plus a one-time
purchase of a file cabinet (estimated cost
$400) to maintain records. The total
estimated annualized burden hours are
7,785.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Responses per
respondent
Average
burden per
response
CFR reference
Data collection instrument
73.7(d) ........................
73.7(d) ........................
73.7(d) ........................
73.7(d) ........................
73.7(h)(1) ....................
73.19(a)(b) ..................
73.5 & 73.6 (d–e)/
73.3 & 73.4 (e)(1).
73.16 ...........................
73.5 & 73.6 (a)(b) .......
73.10(e) ......................
73.9(a)(5) ....................
73.15(c) ......................
73.20 ...........................
73.17 ...........................
Registration application form ........................................................
Additional investigators .................................................................
Additional investigators .................................................................
Additional investigators .................................................................
Amendment to registration application .........................................
Report of theft, loss, or release ....................................................
Request for exemption form/exclusion .........................................
350
245
53
52
350
12
17
1
2
4
9
2
1
1
3.75
45/60
45/60
45/60
1
1
1
Request to transfer .......................................................................
Report of identification ..................................................................
Request expedited review ............................................................
Documentation of self-inspection .................................................
Documentation of training .............................................................
Administrative review ....................................................................
Ensure secure recordkeeping system ..........................................
350
325
10
350
350
15
350
2
4
1
1
1
1
1
1.5
1
30/60
1
2
4
4
Dated: January 18, 2006.
Betsey Dunaway,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E6–808 Filed 1–23–06; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Final Effect of Designation of a Class
of Employees for Addition to the
Special Exposure Cohort
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
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AGENCY:
SUMMARY: The Department of Health and
Human Services (HHS) gives notice
concerning the final effect of the HHS
decision to designate a class of
employees at the Linde Ceramics Plant,
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14:44 Jan 23, 2006
Jkt 208001
in Tonawanda, New York, as an
addition to the Special Exposure Cohort
(SEC) under the Energy Employees
Occupational Illness Compensation
Program Act of 2000. On December 8,
2005, as provided for under 42 U.S.C.
7384q(b), the Secretary of HHS
designated the following class of
employees as an addition to the SEC:
Atomic weapons employees who worked at
the Linde Ceramics Plant from October 1,
1942, through October 31, 1947, and who
were employed for a number of work days
aggregating at least 250 work days either
solely under this employment or in
combination with work days occurring
within the parameters (excluding aggregate
work day requirements) established for other
classes of employees included in the SEC.
FOR FURTHER INFORMATION CONTACT:
Larry Elliott, Director, Office of
Compensation Analysis and Support,
National Institute for Occupational
Safety and Health, 4676 Columbia
Parkway, MS C–46, Cincinnati, OH
45226, Telephone 513–533–6800 (this is
not a toll-free number). Information
requests can also be submitted by e-mail
to OCAS@CDC.GOV.
Dated: January 17, 2006.
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 06–593 Filed 1–23–06; 8:45 am]
BILLING CODE 4163–19–M
This designation became effective on
January 7, 2006, as provided for under
42 U.S.C. 7384l(14)(C). Hence,
beginning on January 7, 2006, members
of this class of employees, defined as
reported in this notice, became members
of the Special Exposure Cohort.
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]]>Agencies
[Federal Register Volume 71, Number 15 (Tuesday, January 24, 2006)]
[Notices]
[Pages 3851-3852]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-808]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-06-0576]
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) 639-4766 or send an e-mail
to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC or by fax to (202) 395-6974.
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)--Revision--Office of the Director (OD), Centers
for Disease Control and Prevention (CDC).
Background and Brief Description
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (Pub. L. 107-188) specifies that the Secretary of
Health and Human Services (HHS) shall provide for the establishment and
enforcement of standards and procedures governing the possession, use,
and transfer of select agents and toxins that have the potential to
pose a severe threat to public health and safety. The Act specifies
that entities that possess, use, and transfer these select agents
register with the HHS Secretary. The HHS Secretary has designated CDC
as the agency responsible for collecting this information.
CDC is requesting continued OMB approval to collect this
information through the use of five separate forms. These forms are:
(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.
The Application for Registration (42 CFR, 73.7(d)) is used by
entities to register with CDC. The Application for Registration
requests facility information; a list of select agents or toxins in
use, possession, or for transfer by the entity; characterization of the
select agent or toxin; and laboratory information. Estimated average
time to complete this form is 3 hours, 45 minutes for an entity with
one principal investigator working with one select agent or toxin. CDC
estimates that entities will need an additional 45 minutes for each
additional investigator or agent. In our regulatory analysis, we have
estimated that 70% of the 350 entities have 1-3 principal
investigators, 15% have 5 principal investigators, and 15% have 10
principal investigators. We have used these figures to calculate the
burden for this section. Estimated burden for the Application for
Registration is 2,191 hours.
Entities may amend their registration (42 CFR, 73.7(h)(1)) if any
changes occur in the information submitted to CDC. To apply for an
amendment to a certificate of registration, an entity must obtain the
relevant portion of the application package and submit the information
requested in the package to CDC. Estimated time to amend a registration
package is 1 hour.
The Request to Transfer Select Agent or Toxin form (42 CFR 73.16)
is used by entities requesting transfer of a select agent or toxin to
their facility and by the entity transferring the agent. CDC revised
the Request to Transfer Select Agent or Toxin form by removing the
requirement that entities provide written notice within five business
days when select agents or toxins are consumed or destroyed after a
transfer. Estimated average time to complete this form is 1 hour, 30
minutes.
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.
The Report of Identification of Select Agent or Toxin form 42 CFR
73.5(a)(b) and 73.6(a)(b)) is 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 is used by Federal law
enforcement agencies to report the seizure and final disposition of
select agents and toxins. Estimated average time to complete this form
is 1 hour.
The Request for Exemption form (42 CFR 73.5 (d)(e) and 73.6 (d)(e))
is used by entities that are using an investigational product that are,
bear, or contain select agents or toxins or in cases of public health
emergency. Estimated average time to complete this form is 1 hour.
In addition to the standardized forms, this regulation also
outlines situations in which an entity must notify or may make a
request of the HHS Secretary in writing. An entity may apply to the HHS
Secretary for an expedited review of an individual by the Attorney
General (42 CFR 73.10(e)). To apply for this expedited review, an
entity must submit a request in writing to the HHS Secretary
establishing the need for such action. The estimated time to gather the
information and submit this request is 30 minutes. CDC has not
developed standardized forms to use in the above situations. Rather,
the entity should
[[Page 3852]]
provide the information as requested in the appropriate section of the
regulation.
An entity may also apply to the HHS Secretary for an exclusion of
an attenuated strain of a select agent or toxin that does not pose a
severe threat to public health and safety (42 CFR 73.3(e)(1) and
73.4(e)(1)). The estimated time to gather the information and submit
this request is 1 hour.
As part of the requirements of the Responsible Official, the
Responsible Official is required to conduct regular inspections (at
least annually) of the laboratory where select agents or toxins are
stored. Results of these self-inspections must be documented (42 CFR
73.9(a)(5)). CDC estimates, that, on average, such documentation will
take 1 hour.
As part of the training requirements of this regulation, the entity
is required to record the identity of the individual trained, the date
of training, and the means used to verify that the employee understood
the training (42 CFR 73.15(c)). Estimated time for this documentation
is 2 hours per principal investigator.
An individual or entity may request administrative review of a
decision denying or revoking certification of registration or an
individual may appeal a denial of access approval (42 CFR 73.20). This
request must be made in writing and within 30 calendar days after the
adverse decision. This request should include a statement of the
factual basis for the review. CDC estimates the time to prepare and
submit such a request is 4 hours.
Finally, an entity must implement a system to ensure that certain
records and databases are accurate and that the authenticity of records
may be verified (42 CFR 73.17(b)). The time to implement such a system
is estimated to average 4 hours.
The cost to respondents is their time to complete the forms and
comply with the reporting and recordkeeping components of the Act plus
a one-time purchase of a file cabinet (estimated cost $400) to maintain
records. The total estimated annualized burden hours are 7,785.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Data collection Number of Responses per Average burden
CFR reference instrument respondents respondent per response
----------------------------------------------------------------------------------------------------------------
73.7(d)........................... Registration application 350 1 3.75
form.
73.7(d)........................... Additional investigators. 245 2 45/60
73.7(d)........................... Additional investigators. 53 4 45/60
73.7(d)........................... Additional investigators. 52 9 45/60
73.7(h)(1)........................ Amendment to registration 350 2 1
application.
73.19(a)(b)....................... Report of theft, loss, or 12 1 1
release.
73.5 & 73.6 (d-e)/ 73.3 & 73.4 Request for exemption 17 1 1
(e)(1). form/exclusion.
73.16............................. Request to transfer...... 350 2 1.5
73.5 & 73.6 (a)(b)................ Report of identification. 325 4 1
73.10(e).......................... Request expedited review. 10 1 30/60
73.9(a)(5)........................ Documentation of self- 350 1 1
inspection.
73.15(c).......................... Documentation of training 350 1 2
73.20............................. Administrative review.... 15 1 4
73.17............................. Ensure secure 350 1 4
recordkeeping system.
----------------------------------------------------------------------------------------------------------------
Dated: January 18, 2006.
Betsey Dunaway,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E6-808 Filed 1-23-06; 8:45 am]
BILLING CODE 4163-18-P
