Proposed Collection; Comment Request; The Prevalence and Incidence of HIV Molecular Variants and Their Correlation With Risk Behaviors and HIV Treatment in Brazilian Blood Donors, 30951-30952 [E8-11921]
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30951
Federal Register / Vol. 73, No. 104 / Thursday, May 29, 2008 / Notices
I. Background
In the Federal Register of January 30,
1998 (63 FR 4571), FDA published a
final rule that revised 21 CFR 814.44(d)
and 814.45(d) to discontinue individual
publication of PMA approvals and
denials in the Federal Register. Instead,
the agency now posts this information
on the Internet on FDA’s home page at
https://www.fda.gov. FDA believes that
this procedure expedites public
notification of these actions because
announcements can be placed on the
Internet more quickly than they can be
published in the Federal Register, and
FDA believes that the Internet is
accessible to more people than the
Federal Register.
In accordance with section 515(d)(4)
and (e)(2) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C.
360e(d)(4) and (e)(2)), notification of an
order approving, denying, or
withdrawing approval of a PMA will
continue to include a notice of
opportunity to request review of the
order under section 515(g) of the act.
The 30-day period for requesting
reconsideration of an FDA action under
§ 10.33(b) (21 CFR 10.33(b)) for notices
announcing approval of a PMA begins
on the day the notice is placed on the
Internet. Section 10.33(b) provides that
FDA may, for good cause, extend this
30-day period. Reconsideration of a
denial or withdrawal of approval of a
PMA may be sought only by the
applicant; in these cases, the 30-day
period will begin when the applicant is
notified by FDA in writing of its
decision.
The regulations provide that FDA
publish a quarterly list of available
safety and effectiveness summaries of
PMA approvals and denials that were
announced during that quarter. The
following is a list of approved PMAs for
which summaries of safety and
effectiveness were placed on the
Internet from October 1, 2007, through
December 31, 2007. There were no
denial actions during this period. The
list provides the manufacturer’s name,
the product’s generic name or the trade
name, and the approval date.
TABLE 1.—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM OCTOBER 1,
2007, THROUGH DECEMBER 31, 2007.
PMA No./Docket No.
Applicant
TRADE NAME
Approval Date
P000009 (S4)/2007M–
0408
Biotronik, Inc.
TACHOS DR ATRIAL TX IMPLANTABLE CARDIOVERTER
DEFIBRILLATOR ICD SYSTEM
September 9, 2002
P060031/2007M–0467
Bio-Rad Laboratories
BIO–RAD MONOLISA ANTI–HBC EIA
April 27, 2007
P060005/2007M–0409
Siemens Medical Solutions Diagnostics
IMMULITE/IMMULITE 1000 & IMMULITE 2000 FREE PSA
ASSAYS
May 11, 2007
P060017/2007M–0413
Veridex, LLC
GENESEARCH BREAST LYMPH NODE (BLN) ASSAY
July 16, 2007
P040040/2007M–0446
AGA Medical Corp.
AMPLATZER MUSCULAR VSD
September 7, 2007
P070009/2007M–0380
Obtech Medical GMBH
REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200–X
September 28, 2007
P070012/2007M–0411
Medtronic Vascular
EXPONENT SELF-EXPANDING CAROTIC STENT SYSTEM
WITH OVER THE WIRE OR RAPID EXHANGE DELIVERY
SYSTEM
October 23, 2007
P060038/2007M–0410
Carbomedics, Inc.
MITROFLOW AORTIC PERICARDIAL HEART VALVE
October 23, 2007
H990002/2007M–0415
Genzyme Biosurgery
EPICEL (CULTURED EPIDERMAL AUTOGRAFTS)
October 25, 2007
P060035/2007M–0447
Abbott Laboratories
ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS
November 6, 2007
II. Electronic Access
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
National Institutes of Health
Dated: May 16, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological
Health.
[FR Doc. E8–12012 Filed 5–28–08; 8:45 am]
jlentini on PROD1PC65 with NOTICES
BILLING CODE 4160–01–S
VerDate Aug<31>2005
17:45 May 28, 2008
Proposed Collection; Comment
Request; The Prevalence and
Incidence of HIV Molecular Variants
and Their Correlation With Risk
Behaviors and HIV Treatment in
Brazilian Blood Donors
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
Jkt 214001
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
projects to the Office of Management
and Budget (OMB) for review and
approval.
Proposed Collection: Title: The
Prevalence and Incidence of HIV
Molecular Variants and Their
Correlation With Risk Behaviors and
HIV Treatment in Brazilian Blood
Donors. Type of Information Collection
Request: NEW. Need and Use of
Information Collection: Establishing and
monitoring viral prevalence and
incidence rates, and identifying risk
behaviors for HIV incidence among
blood donors, are critical to assessing
and reducing risk of HIV transmission
through blood transfusion. Identifying
donation samples from donors with
recent HIV infection is particularly
critical as it enables characterization of
E:\FR\FM\29MYN1.SGM
29MYN1
30952
Federal Register / Vol. 73, No. 104 / Thursday, May 29, 2008 / Notices
the viral subtypes currently transmitted
within the screened population and
hence most likely to ‘‘break-through’’
routine screening measures (i.e., periseroconversion window period
donations). Molecular surveillance of
incident HIV infections in blood donors
not only characterizes genotypes of
recently infected donors for purposes of
blood safety, but also enables
documentation of the rates of primary
transmission of anti-viral drug resistant
strains in the community, serving a
public health role in identifying new
HIV infections for anti-retroviral
treatment. Both a prospective
surveillance and a case-control design
are proposed to enroll all eligible HIV
seropositives detected at three blood
˜
centers in Brazil (Sao Paulo, Belo
´
Horizante, and Recıfe) plus a satellite
center in Rio de Janeiro. A comparison
of epidemiological risk profiles will be
made between the seropositive donors
and a group of randomly selected
seronegative donors.
There are three study aims.
Laboratory studies (LS–EIA testing and
sequencing of pol region) on linked
specimens from all enrolled HIV cases,
will allow for estimation of HIV
prevalence and incidence relative to
genotype and putative route of
infection. Data derived from molecular
genotyping, including drug resistant
genotypes, will be provided, along with
counseling, to all enrolled HIV positive
donors to facilitate their clinical care via
referral to the Brazilian national HIV
treatment system. Our findings will be
compared to trends in prevalence,
incidence and molecular variants from
studies of the general population and
high risk populations in Brazil, thus
allowing for broad monitoring of the
HIV epidemic in Brazil and assessment
of the impact of donor selection criteria
on these parameters. Finally, HIV cases
and a group of controls, through
responses to a questionnaire, will
provide data on HIV risk behaviors
among prospective blood donors. This
HIV risk behavior data will be used as
covariates in the molecular surveillance
analyses described above, as well as aid
in assessing whether modifications may
be needed to Brazil’s routine blood
center operational donor screening
questionnaire.
The study participants will return to
their local blood center for the
administration of an informed consent
form, explaining the confidential nature
of the research study as well as the risks
and benefits to their participation. Once
enrolled, they will be asked to complete
the self-administered risk factor
questionnaire. In addition, a small blood
sample will be collected from each HIV
seropositive participant to be used for
the genotyping and drug resistance
testing. The results of the drug
resistance testing will be communicated
back to the seropositive participants
during an in-person counseling session
at the blood center. Defining prevalence
and incidence in blood donors and
residual risk of HIV transmission by
Estimated
number of
responses per
respondent
Estimated
number of
respondents
jlentini on PROD1PC65 with NOTICES
2,000 ................................................................................................................................
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address 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 the assumptions used;
(3) Ways to enhance the quality, utility,
and clarity of the information 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
VerDate Aug<31>2005
17:45 May 28, 2008
Jkt 214001
transfusions may lead to new
regulations and blood safety initiatives
in Brazil. The data can be used to
project the yield, safety impact and cost
effectiveness of implementing enhanced
testing strategies such as combination
antigen-antibody assays and/or NAT.
Determination of HIV risk factors in
donors (first time versus repeat donor
status; volunteer versus replacement
status; demographics and risk
behaviors) will support policy
discussions over strategies to recruit the
safest possible donors in Brazil. The
findings from this project will also
complement similar monitoring of HIV
prevalence, incidence, transfusion risk
and molecular variants in the U.S. and
other funded international REDS-II sites,
thus allowing direct comparisons of
these parameters on a global level.
Frequency of Response: Once.
Affected Public: Individuals. Type of
Respondents: Adult Blood Donors. The
annual reporting burden is as follows:
Estimated Number of Respondents:
2,000; Estimated Number of Responses
per Respondent: 1; Average Burden of
Hours per Response: 0.40 (including
administration of the informed consent
form and questionnaire completion
instructions); and Estimated Total
Annual Burden Hours Requested: 800.
The annualized cost to respondents is
estimated at: $5,200 (based on $6.50 per
hour). There are no Capital Costs to
report. There are no Operating or
Maintenance Costs to report.
collection techniques or other forms of
information technology.
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, Room 9144, 6701 Rockledge
Drive, MSC 7950, Bethesda, MD 20892–
7950, or call 301–435–0065, orE-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 60 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT:
PO 00000
Average burden
hours per
response
1
Estimated
total annual
burden hours
requested
0.40
800
Dated: May 20, 2008.
George Nemo,
Project Officer, NHLBI, National Institutes of
Health.
[FR Doc. E8–11921 Filed 5–28–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Frm 00073
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]]>Agencies
[Federal Register Volume 73, Number 104 (Thursday, May 29, 2008)]
[Notices]
[Pages 30951-30952]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-11921]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; The Prevalence and
Incidence of HIV Molecular Variants and Their Correlation With Risk
Behaviors and HIV Treatment in Brazilian Blood Donors
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: The Prevalence and Incidence of HIV
Molecular Variants and Their Correlation With Risk Behaviors and HIV
Treatment in Brazilian Blood Donors. Type of Information Collection
Request: NEW. Need and Use of Information Collection: Establishing and
monitoring viral prevalence and incidence rates, and identifying risk
behaviors for HIV incidence among blood donors, are critical to
assessing and reducing risk of HIV transmission through blood
transfusion. Identifying donation samples from donors with recent HIV
infection is particularly critical as it enables characterization of
[[Page 30952]]
the viral subtypes currently transmitted within the screened population
and hence most likely to ``break-through'' routine screening measures
(i.e., peri-seroconversion window period donations). Molecular
surveillance of incident HIV infections in blood donors not only
characterizes genotypes of recently infected donors for purposes of
blood safety, but also enables documentation of the rates of primary
transmission of anti-viral drug resistant strains in the community,
serving a public health role in identifying new HIV infections for
anti-retroviral treatment. Both a prospective surveillance and a case-
control design are proposed to enroll all eligible HIV seropositives
detected at three blood centers in Brazil (S[atilde]o Paulo, Belo
Horizante, and Rec[iacute]fe) plus a satellite center in Rio de
Janeiro. A comparison of epidemiological risk profiles will be made
between the seropositive donors and a group of randomly selected
seronegative donors.
There are three study aims. Laboratory studies (LS-EIA testing and
sequencing of pol region) on linked specimens from all enrolled HIV
cases, will allow for estimation of HIV prevalence and incidence
relative to genotype and putative route of infection. Data derived from
molecular genotyping, including drug resistant genotypes, will be
provided, along with counseling, to all enrolled HIV positive donors to
facilitate their clinical care via referral to the Brazilian national
HIV treatment system. Our findings will be compared to trends in
prevalence, incidence and molecular variants from studies of the
general population and high risk populations in Brazil, thus allowing
for broad monitoring of the HIV epidemic in Brazil and assessment of
the impact of donor selection criteria on these parameters. Finally,
HIV cases and a group of controls, through responses to a
questionnaire, will provide data on HIV risk behaviors among
prospective blood donors. This HIV risk behavior data will be used as
covariates in the molecular surveillance analyses described above, as
well as aid in assessing whether modifications may be needed to
Brazil's routine blood center operational donor screening
questionnaire.
The study participants will return to their local blood center for
the administration of an informed consent form, explaining the
confidential nature of the research study as well as the risks and
benefits to their participation. Once enrolled, they will be asked to
complete the self-administered risk factor questionnaire. In addition,
a small blood sample will be collected from each HIV seropositive
participant to be used for the genotyping and drug resistance testing.
The results of the drug resistance testing will be communicated back to
the seropositive participants during an in-person counseling session at
the blood center. Defining prevalence and incidence in blood donors and
residual risk of HIV transmission by transfusions may lead to new
regulations and blood safety initiatives in Brazil. The data can be
used to project the yield, safety impact and cost effectiveness of
implementing enhanced testing strategies such as combination antigen-
antibody assays and/or NAT. Determination of HIV risk factors in donors
(first time versus repeat donor status; volunteer versus replacement
status; demographics and risk behaviors) will support policy
discussions over strategies to recruit the safest possible donors in
Brazil. The findings from this project will also complement similar
monitoring of HIV prevalence, incidence, transfusion risk and molecular
variants in the U.S. and other funded international REDS-II sites, thus
allowing direct comparisons of these parameters on a global level.
Frequency of Response: Once. Affected Public: Individuals. Type of
Respondents: Adult Blood Donors. The annual reporting burden is as
follows: Estimated Number of Respondents: 2,000; Estimated Number of
Responses per Respondent: 1; Average Burden of Hours per Response: 0.40
(including administration of the informed consent form and
questionnaire completion instructions); and Estimated Total Annual
Burden Hours Requested: 800. The annualized cost to respondents is
estimated at: $5,200 (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 Average burden Estimated total
Estimated number of respondents responses per hours per annual burden
respondent response hours requested
----------------------------------------------------------------------------------------------------------------
2,000..................................................... 1 0.40 800
----------------------------------------------------------------------------------------------------------------
Request for Comments: Written comments and/or suggestions from the
public and affected agencies should address 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 the assumptions used; (3) Ways to enhance the quality, utility, and
clarity of the information 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.
FOR FURTHER INFORMATION CONTACT: 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, Room 9144, 6701 Rockledge Drive, MSC 7950, Bethesda,
MD 20892-7950, or call 301-435-0065, orE-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 60 days
of the date of this publication.
Dated: May 20, 2008.
George Nemo,
Project Officer, NHLBI, National Institutes of Health.
[FR Doc. E8-11921 Filed 5-28-08; 8:45 am]
BILLING CODE 4140-01-P
