Centers for Disease Control and Prevention Proposed Data Collections Submitted for Public Comment and Recommendations, 8366-8367 [2010-3702]
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8366
Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Notices
Dated: February 17, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–3756 Filed 2–23–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[60 Day–10–0639]
Centers for Disease Control and
Prevention Proposed Data Collections
Submitted for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 or send
comments to Maryam Daneshvar, CDC
Acting Reports Clearance Officer, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an e-mail to
omb@cdc.gov.
Comments are invited 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)
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
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments must be
received within 60 days of this notice.
Project Proposal
pwalker on DSK8KYBLC1PROD with NOTICES
EEOICPA Special Exposure Cohort
Petitions (OMB No. 0920–0639 exp. 7/
31/2010)—Extension—National Institute
for Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
On October 30, 2000, the Energy
Employees Occupational Illness
VerDate Nov<24>2008
16:49 Feb 23, 2010
Jkt 220001
Compensation Program Act of 2000
(EEOICPA), 42 U.S.C. 7384–7385 [1994,
supp. 2001] was enacted. It established
a compensation program to provide a
lump sum payment of $150,000 and
medical benefits as compensation to
covered employees suffering from
designated illnesses incurred as a result
of their exposure to radiation,
beryllium, or silica while in the
performance of duty for the Department
of Energy and certain of its vendors,
contractors and subcontractors. This
legislation also provided for payment of
compensation for certain survivors of
these covered employees. This program
has been mandated to be in effect until
Congress ends the funding.
Among other duties, HHS was
directed to establish and implement
procedures for considering petitions by
classes of nuclear weapons workers to
be added to the ‘‘Special Exposure
Cohort’’ (the ‘‘Cohort’’). In brief,
EEOICPA authorizes HHS to designate
such classes of employees for addition
to the Cohort when NIOSH lacks
sufficient information to estimate with
sufficient accuracy the radiation doses
of the employees, if HHS also finds that
the health of members of the class may
have been endangered by the radiation
dose the class potentially incurred. HHS
must also obtain the advice of the
Advisory Board on Radiation and
Worker Health (the ‘‘Board’’) in
establishing such findings. On May 28,
2004, HHS issued a rule that established
procedures for adding such classes to
the Cohort (42 CFR part 83). The rule
was amended on July 10, 2007.
The HHS rule authorizes a variety of
respondents to submit petitions.
Petitioners are required to provide the
information specified in the rule to
qualify their petitions for a complete
evaluation by HHS and the Board. HHS
has developed two forms to assist the
petitioners in providing this required
information efficiently and completely.
Form A is a one-page form to be used
by EEOICPA claimants for whom
NIOSH has attempted to conduct dose
reconstructions and has determined that
available information is not sufficient to
complete the dose reconstruction. Form
B, accompanied by separate
instructions, is intended for all other
petitioners. Forms A and B can be
submitted electronically as well as in
hard copy. Respondent/petitioners
should be aware that HHS is not
requiring respondents to use the forms.
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
Respondents can choose to submit
petitions as letters or in other formats,
but petitions must meet the
informational requirements referenced
above. NIOSH expects, however, that all
petitioners for whom Form A would be
appropriate will actually use the form,
since NIOSH will provide it to them
upon determining that their dose
reconstruction cannot be completed and
encourage them to submit the petition.
NIOSH expects the large majority of
petitioners for whom Form B would be
appropriate will also use the form, since
it provides a simple, organized format
for addressing the informational
requirements of a petition.
NIOSH will use the information
obtained through the petition for the
following purposes: (a) Identify the
petitioner(s), obtain their contact
information, and establish that the
petitioner(s) is qualified and intends to
petition HHS; (b) establish an initial
definition of the class of employees
being proposed to be considered for
addition to the Cohort; (c) determine
whether there is justification to require
HHS to evaluate whether or not to
designate the proposed class as an
addition to the Cohort (such an
evaluation involves potentially
extensive data collection, analysis, and
related deliberations by NIOSH, the
Board, and HHS); and, (d) target an
evaluation by HHS to examine relevant
potential limitations of radiation
monitoring and/or dosimetry-relevant
records and to examine the potential for
related radiation exposures that might
have endangered the health of members
of the class.
Finally, under the rule, petitioners
may contest the proposed decision of
the Secretary to add or deny adding
classes of employees to the cohort by
submitting evidence that the proposed
decision relies on a record of either
factual or procedural errors in the
implementation of these procedures.
NIOSH estimates that the time to
prepare and submit such a challenge is
45 minutes. Because of the uniqueness
of this submission, NIOSH is not
providing a form. The submission will
typically be in the form of a letter to the
Secretary.
There are no costs to petitioners
unless a petitioner chooses to purchase
the services of an expert in dose
reconstruction, an option provided for
under the rule.
E:\FR\FM\24FEN1.SGM
24FEN1
8367
Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Notices
ESTIMATE OF ANNUALIZED BURDEN HOURS
Type of respondent
Form A 83.9 ......
Form B 83.9 ......
Form B 83.9 ......
Petitioner using Form A ....................................................
Petitioner using Form B ....................................................
Petitioner submission format other than Form B (as permitted by rule).
Petitioner Appealing final HHS decision (no specific form
is required).
Claimant authorizing a party to submit petition on his/her
behalf.
83.18 .................
Total ...........
...........................................................................................
Dated: February 18, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–3702 Filed 2–23–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
pwalker on DSK8KYBLC1PROD with NOTICES
Proposed Collection; Comment
Request; REDS—II—Does PreDonation Behavioral Deferral Increase
the Safety of the Blood Supply?
SUMMARY: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Heart, Lung, and Blood
Institute (NHLBI), the National
Institutes of Health (NIH), will publish
periodic summaries of proposed
projects to the Office of Management
and Budget (OMB) for review and
approval.
Proposed Collection: Title: REDS–II
Does Pre-Donation Behavioral Deferral
Increase the Safety of the Blood Supply?
Type of Information Collection
Request: NEW. Need and Use of
Information Collection: While it is wellaccepted that deferrals, as part of the
‘‘layers of safety’’ concept, increase the
safety of the blood supply, studies with
sufficiently large sample size to quantify
HIV infection and other infectious
marker rates in deferred donors are
lacking. Evidence in support of
increased safety is frequently inferred
from studies conducted in other health
care settings. For example, a small
hospital-based case control study
conducted in Brazil examined the
association between infectious markers
and body tattoos. Even though tattoos
are not used as a criteria to determine
VerDate Nov<24>2008
16:49 Feb 23, 2010
Jkt 220001
No. of
responses per
respondent
No. of
respondents
Form name
Frm 00074
Fmt 4703
Sfmt 4703
Total response
burden hours
30
40
5
1
1
1
3/60
5
6
2
200
30
5
1
45/60
4
20
1
3/60
1
100
........................
........................
237
blood donor eligibility in Brazil, having
a tattoo was associated with HCV and
also with having at least one positive
infectious marker. (1) Significant
associations were not independently
observed for HIV, HBV, syphilis or
Chagas. The authors reported an overall
sensitivity of 11% and specificity of
97% for the presence of a tattoo as
indicator of having HIV, HCV, HBV, or
syphilis infection. The researchers then
estimated the impact on blood donor
selection and disease marker testing
using the results from their hospitalbased case control study. However, the
assumptions such as disease marker
prevalence of as much as 15% in donors
who are deferred for tattoos and a
prevalence of 4% of the potential donor
base having a tattoo (2) do not represent
current temporary deferrals in Brazil
and do not address the most common
behavior-related deferrals. A more
detailed and targeted assessment of the
value of relevant deferrals could be used
to help inform blood donation policies
in Brazil.
In Brazilian blood collection centers,
donor deferral is initiated either by the
blood center staff, based on information
disclosed by prospective donors, or by
the donor through self-deferral. Either
type of deferral occurs because of the
belief that a donor’s behavior,
exposures, or history represents an
increased risk to the safety of the blood
supply
Although the general eligibility
criteria are mandated by the Brazilian
Ministry of Health, the specific criteria
for screening potential donors and the
procedures for implementing them may
vary across the regional blood collection
centers. This study will focus on sexual
behavior deferrals and their impact on
blood safety. The two main study aims
are: (1) To assess infectious disease
marker prevalence in donors who are
deferred for higher risk sexual and noninjection drug use behavior; and (2) To
PO 00000
Average
burden per
respondent
(in hours)
determine if the different deferral
classification procedures used by
different blood centers in Brazil lead to
a measurable difference in disease
marker prevalence in deferred donors.
To do this, deferred donors who agree
to participate in this study will be asked
to complete an audio computer assisted
self interview (ACASI) questionnaire
that measures two content areas (1)
motivations for attempting to donate, (2)
additional information on the deferral
and other potentially undisclosed
deferrable behaviors. A blood sample
will be collected from the deferred
donors and tested for the panel of
infections currently screened for in
Brazil (HIV, Hepatitis C, Hepatitis B,
Human T-lymphotropic virus, syphilis,
and Trypanosoma cruzi) using the same
high-throughput laboratory reagents and
procedures that are used to screen
donations. These deferred donor marker
rates will be compared to the marker
rates among accepted donors with the
same demographic characteristics.
Marker rates in deferred donors will
also be compared between the blood
centers.
Frequency of Response: Once.
Affected Public: Individuals. Type of
Respondents: Adult Blood Donors. The
annual reporting burden is as follows:
Estimated Number of Respondents:
4,860; Estimated Number of Responses
per Respondent: 1; Average Burden of
Hours per Response: 0.33 (including
administration of the informed consent
form and questionnaire completion
instructions); and Estimated Total
Annual Burden Hours Requested: 1,620.
The annualized cost to respondents is
estimated at: $10,530 (based on $6.50
per hour). There are no Capital Costs to
report. There are no Operating or
Maintenance Costs to report.
E:\FR\FM\24FEN1.SGM
24FEN1
Agencies
[Federal Register Volume 75, Number 36 (Wednesday, February 24, 2010)]
[Notices]
[Pages 8366-8367]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3702]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[60 Day-10-0639]
Centers for Disease Control and Prevention Proposed Data
Collections Submitted for Public Comment and Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-5960 or
send comments to Maryam Daneshvar, CDC Acting Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail
to omb@cdc.gov.
Comments are invited 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) 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 on respondents,
including through the use of automated collection techniques or other
forms of information technology. Written comments must be received
within 60 days of this notice.
Project Proposal
EEOICPA Special Exposure Cohort Petitions (OMB No. 0920-0639 exp.
7/31/2010)--Extension--National Institute for Occupational Safety and
Health (NIOSH), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
On October 30, 2000, the Energy Employees Occupational Illness
Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384-7385 [1994,
supp. 2001] was enacted. It established a compensation program to
provide a lump sum payment of $150,000 and medical benefits as
compensation to covered employees suffering from designated illnesses
incurred as a result of their exposure to radiation, beryllium, or
silica while in the performance of duty for the Department of Energy
and certain of its vendors, contractors and subcontractors. This
legislation also provided for payment of compensation for certain
survivors of these covered employees. This program has been mandated to
be in effect until Congress ends the funding.
Among other duties, HHS was directed to establish and implement
procedures for considering petitions by classes of nuclear weapons
workers to be added to the ``Special Exposure Cohort'' (the
``Cohort''). In brief, EEOICPA authorizes HHS to designate such classes
of employees for addition to the Cohort when NIOSH lacks sufficient
information to estimate with sufficient accuracy the radiation doses of
the employees, if HHS also finds that the health of members of the
class may have been endangered by the radiation dose the class
potentially incurred. HHS must also obtain the advice of the Advisory
Board on Radiation and Worker Health (the ``Board'') in establishing
such findings. On May 28, 2004, HHS issued a rule that established
procedures for adding such classes to the Cohort (42 CFR part 83). The
rule was amended on July 10, 2007.
The HHS rule authorizes a variety of respondents to submit
petitions. Petitioners are required to provide the information
specified in the rule to qualify their petitions for a complete
evaluation by HHS and the Board. HHS has developed two forms to assist
the petitioners in providing this required information efficiently and
completely. Form A is a one-page form to be used by EEOICPA claimants
for whom NIOSH has attempted to conduct dose reconstructions and has
determined that available information is not sufficient to complete the
dose reconstruction. Form B, accompanied by separate instructions, is
intended for all other petitioners. Forms A and B can be submitted
electronically as well as in hard copy. Respondent/petitioners should
be aware that HHS is not requiring respondents to use the forms.
Respondents can choose to submit petitions as letters or in other
formats, but petitions must meet the informational requirements
referenced above. NIOSH expects, however, that all petitioners for whom
Form A would be appropriate will actually use the form, since NIOSH
will provide it to them upon determining that their dose reconstruction
cannot be completed and encourage them to submit the petition. NIOSH
expects the large majority of petitioners for whom Form B would be
appropriate will also use the form, since it provides a simple,
organized format for addressing the informational requirements of a
petition.
NIOSH will use the information obtained through the petition for
the following purposes: (a) Identify the petitioner(s), obtain their
contact information, and establish that the petitioner(s) is qualified
and intends to petition HHS; (b) establish an initial definition of the
class of employees being proposed to be considered for addition to the
Cohort; (c) determine whether there is justification to require HHS to
evaluate whether or not to designate the proposed class as an addition
to the Cohort (such an evaluation involves potentially extensive data
collection, analysis, and related deliberations by NIOSH, the Board,
and HHS); and, (d) target an evaluation by HHS to examine relevant
potential limitations of radiation monitoring and/or dosimetry-relevant
records and to examine the potential for related radiation exposures
that might have endangered the health of members of the class.
Finally, under the rule, petitioners may contest the proposed
decision of the Secretary to add or deny adding classes of employees to
the cohort by submitting evidence that the proposed decision relies on
a record of either factual or procedural errors in the implementation
of these procedures. NIOSH estimates that the time to prepare and
submit such a challenge is 45 minutes. Because of the uniqueness of
this submission, NIOSH is not providing a form. The submission will
typically be in the form of a letter to the Secretary.
There are no costs to petitioners unless a petitioner chooses to
purchase the services of an expert in dose reconstruction, an option
provided for under the rule.
[[Page 8367]]
Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
No. of Average burden
Form name Type of respondent No. of responses per per respondent Total response
respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Form A 83.9............... Petitioner using 30 1 3/60 2
Form A.
Form B 83.9............... Petitioner using 40 1 5 200
Form B.
Form B 83.9............... Petitioner 5 1 6 30
submission format
other than Form B
(as permitted by
rule).
83.18..................... Petitioner Appealing 5 1 45/60 4
final HHS decision
(no specific form
is required).
Claimant authorizing 20 1 3/60 1
a party to submit
petition on his/her
behalf.
-------------------------------------------------------------------------------------
Total................. .................... 100 .............. .............. 237
----------------------------------------------------------------------------------------------------------------
Dated: February 18, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. 2010-3702 Filed 2-23-10; 8:45 am]
BILLING CODE 4163-18-P