Submission for OMB Review; Comment Request; REDS-II-Does Pre-Donation Behavioral Deferral Increase the Safety of the Blood Supply?, 25268-25269 [2010-10899]
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25268
Federal Register / Vol. 75, No. 88 / Friday, May 7, 2010 / Notices
the number of respondents for listing of
ingredients under section 904 of the act
from 100,000 to 11,000 in response to
comments that this estimate was too
high. FDA also added the activity of
applying for a Dun and Bradstreet D-U-
N-S number to the burden of this
information collection for those who
chose to use eSubmitter.
In the Federal Register of February
18, 2010 (75 FR 7269), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. One comment was received
but was outside the scope of the PRA
requirements.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN
Number of
Respondents
Activity
Registration and Product
Listing for Owners and
Operators of Domestic
Establishments
Annual Frequency
per Response
Total Annual
Respondents
Hours per
Response
Total Hours
100,000
1
100,000
3.75
375,000
Listing of Ingredients
11,000
1
11,000
3.0
33,000
Obtaining a Dun and
Bradstreet D-U-N-S
Number
1,550
1
1,550
0.5
775
Total
112,550
Dated: May 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–10781 Filed 5–6–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0487]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance on Informed Consent for In
Vitro Diagnostic Device Studies Using
Leftover Human Specimens That Are
Not Individually Identifiable
AGENCY:
Food and Drug Administration,
112,550
FR 2868), the agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0582. The
approval expires on February 28, 2013.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
Dated: May 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–10782 Filed 5–6–10; 8:45 am]
BILLING CODE 4160–01–S
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance on Informed Consent For In
Vitro Diagnostic Device Studies Using
Leftover Human Specimens That Are
Not Individually Identifiable’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, email:
Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of January 19, 2010 (75
jlentini on DSKJ8SOYB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
19:19 May 06, 2010
Jkt 220001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; REDS–II—Does
Pre-Donation Behavioral Deferral
Increase the Safety of the Blood
Supply?
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Heart, Lung and Blood Institute
(NHLBI), the National Institutes of
Health has submitted to the Office of
Management and Budget (OMB) a
request for review and approval of the
information collection listed below.
This proposed information collection
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
408,775
was previously published in the Federal
Register on February 24, 2010 in
Volume 75, No. 36, pages 8367–8368
and allowed 60-days for public
comment. (No public comments were
received.) The purpose of this notice is
to allow an additional 30 days for public
comment. The National Institutes of
Health may not conduct or sponsor, and
the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
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
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
E:\FR\FM\07MYN1.SGM
07MYN1
25269
Federal Register / Vol. 75, No. 88 / Friday, May 7, 2010 / Notices
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
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: 1,604.
The annualized cost to respondents is
estimated at: $10,426 (based on $6.50
per hour). There are no Capital Costs to
report. There are no Operating or
Maintenance Costs to report.
Estimated
number of
responses per
respondent
Estimated number of respondents
jlentini on DSKJ8SOYB1PROD with NOTICES
4,860 ............................................................................................................................................
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’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 those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
VerDate Mar<15>2010
19:19 May 06, 2010
Jkt 220001
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Dr.
George Nemo, Project Officer, NHLBI,
Two Rockledge Center, Suite 10042,
6701 Rockledge Drive, Bethesda, MD
20892–7950, or call 301–435–0075, or Email your request to nemog@nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
Dated: April 29, 2010.
George Nemo,
Project Officer, NHLBI, National Institutes of
Health.
[FR Doc. 2010–10899 Filed 5–6–10; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
1
Average
burden hours
per response
Estimated total
annual burden
hours
requested
0.33
1,604
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; A Generic Submission for
Formative Research, Pretesting, and
Stakeholder Measures at NCI
SUMMARY: Under the provisions 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 Cancer
Institute (NCI), the National Institutes of
Health (NIH) will publish periodic
summaries of proposed projects to be
submitted to the Office of Management
and Budget (OMB) for review and
approval.
Proposed Collection: Title: A Generic
Submission for Formative Research, Pretesting, and Stakeholder Measures at
NCI. Type of Information Collection
Request: New. Need and Use of
Information Collection: In order to carry
out NCI’s legislative mandate, the Office
of Advocacy Relations (OAR)
disseminates cancer-related information
to a variety of stakeholders, seeks their
E:\FR\FM\07MYN1.SGM
07MYN1
]]>Agencies
[Federal Register Volume 75, Number 88 (Friday, May 7, 2010)]
[Notices]
[Pages 25268-25269]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-10899]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; REDS-II--Does Pre-
Donation Behavioral Deferral Increase the Safety of the Blood Supply?
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Heart, Lung and Blood Institute
(NHLBI), the National Institutes of Health has submitted to the Office
of Management and Budget (OMB) a request for review and approval of the
information collection listed below. This proposed information
collection was previously published in the Federal Register on February
24, 2010 in Volume 75, No. 36, pages 8367-8368 and allowed 60-days for
public comment. (No public comments were received.) The purpose of this
notice is to allow an additional 30 days for public comment. The
National Institutes of Health may not conduct or sponsor, and the
respondent is not required to respond to, an information collection
that has been extended, revised, or implemented on or after October 1,
1995, unless it displays a currently valid OMB control number.
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 well-accepted 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 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
[[Page 25269]]
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 hospital-based 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 non-injection
drug use behavior; and (2) To 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: 1,604. The annualized cost to respondents is
estimated at: $10,426 (based on $6.50 per hour). There are no Capital
Costs to report. There are no Operating or Maintenance Costs to report.
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
number of Average total annual
Estimated number of respondents responses per burden hours burden hours
respondent per response requested
----------------------------------------------------------------------------------------------------------------
4,860........................................................... 1 0.33 1,604
----------------------------------------------------------------------------------------------------------------
Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper performance of the function of the agency,
including whether the information will have practical utility; (2) The
accuracy of the agency'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 those who are to
respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: Desk Officer for NIH. To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact: Dr. George Nemo, Project Officer, NHLBI, Two
Rockledge Center, Suite 10042, 6701 Rockledge Drive, Bethesda, MD
20892-7950, or call 301-435-0075, or E-mail your request to
nemog@nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30-days
of the date of this publication.
Dated: April 29, 2010.
George Nemo,
Project Officer, NHLBI, National Institutes of Health.
[FR Doc. 2010-10899 Filed 5-6-10; 8:45 am]
BILLING CODE 4140-01-P
