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]

Download as PDF 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 http://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 http:// 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 Fmt 4703 Sfmt 4703 E:\FR\FM\29MYN1.SGM 29MYN1

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