46628 Federal Register / Vol. 73, No. 155 / Monday, August 11, 2008 / Notices 

Moderator: Ashley Golden 

Moderator E-mail: a_golden@teampsa.com. 

For Further Information Contact: Anyone 

requesting information regarding the 

Committee should contact Louis D. 

Coccodrilli, Designated Federal Official for 

the ACICBL, Bureau of Health Professions, 

Health Resources and Services 

Administration, Parklawn Building, Rm. 9–

36, 5600 Fishers Lane, Rockville, Maryland 

20857; (301) 443–6950 or 

lcoccodrilli@hrsa.gov. Marie Ulysse, HRSA 

Scholar, can also be contacted for inquiries 

at (301) 443–6529 or mulysse@hrsa.gov. 

Dated: August 4, 2008. 

Alexandra Huttinger, 

Director, Division of Policy Review and 

Coordination. 

[FR Doc. E8–18393 Filed 8–8–08; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; The Prevalence 

and Incidence of HIV Molecular 

Variants and Their Correlation With 

Risk Behaviors and HIV Treatment in 

Brazilian Blood Donors 

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 (NIH) has submitted to the Office 

of Management and Budget (OMB) a 

request to review and approve the 

information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on May 29, 2008, pages 30951–

30952 and allowed 60 days for public 

comment. 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 current valid 

OMB control number. 

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 

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 (Sa ̃o Paulo, Belo 

Horizante, and Recı ́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. 


rmajette on PRODPC74 with NOTICES
Federal Register / Vol. 73, No. 155 / Monday, August 11, 2008 / Notices 46629 

Etimated number of respondents 

Estimated number of responses per respondent 

Average burden 

hours per response 

Estimated total 

annual burden 

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. 

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, New Executive 

Office Building, Room 10235, 

Washington, DC 20503, 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, Room 9144, 

6701 Rockledge Drive, MSC 7950, 

Bethesda, MD 20892–7950, or call 301–

435–0065, 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: August 1, 2008. 

George Nemo, 

Project Officer, NHLBI, National Institutes of 

Health. 

[FR Doc. E8–18491 Filed 8–8–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of a meeting of the 

Advisory Committee to the Director, 

National Institutes of Health (NIH). 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal property. 

Name of Committee: Advisory Committee 

to the Director, NIH. 

Date: August 15, 2008. 

Time: 2 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building, 45 Center Drive, Bethesda, 

MD 20892 (Telephone Conference Call). 

Contact Person: Penny Burgoon, Senior 

Assistant to the Deputy Director, Office of the 

Director, National Institutes of Health, 1 

Center Drive, Building 1, Room 114, 

Bethesda, MD 20892, (301) 451–5870, 

burgoonp@od.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

www.nih.gov/about/director/acd.htm, where 

an agenda and any additional information for 

the meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.14, Intramural Research 

Training Award; 93.22, Clinical Research 

Loan Repayment Program for Individuals 

from Disadvantaged Backgrounds; 93.232, 

Loan Repayment Program for Research 

Generally; 93.39, Academic Research 

Enhancement Award; 93.936, NIH Acquired 

Immunodeficiency Syndrome Research Loan 

Repayment Program; 93.187, Undergraduate 

Scholarship Program for Individuals from 

Disadvantaged Backgrounds, National 

Institutes of Health, HHS) 

Dated: August 5, 2008. 

Anna Snouffer, 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–18494 Filed 8–8–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Oncology 

Area. 

Date: September 8, 2008. 

Time: 2 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Lambratu Rahman, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6214, 

MSC 7804, Bethesda, MD 20892, 301–451–

3493, rahmanl@csr.nih.gov. 

Name of Committee: Oncological Sciences 

Integrated Review Group, Cancer Molecular 

Pathobiology Study Section. 

Date: September 15–16, 2008. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 


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