Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Notices 8367 

ESTIMATE OF ANNUALIZED BURDEN HOURS

Form name Type of respondent No. of 

respondents 

No. of 

responses per 

respondent 

Average 

burden per 

respondent 

(in hours) 

Total response 

burden hours 

Form A 83.9 ...... Petitioner using Form A .................................................... 30 1 3/60 2 

Form B 83.9 ...... Petitioner using Form B .................................................... 40 1 5 200 

Form B 83.9 ...... Petitioner submission format other than Form B (as permitted by rule).5 1 6 30 

83.18 ................. Petitioner Appealing final HHS decision (no specific form 

is required).

5 1 45/60 4 

Claimant authorizing a party to submit petition on his/her 

behalf.

20 1 3/60 1 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

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 

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 

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. 


pwalker on DSK8KYBLC1PROD with NOTICES
8368 Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Notices 

Estimated number of respondents 

Estimated number of responses 

per respondent 

Average burden 

hours per response 

Estimated total 

annual burden 

hours requested 

4,860 ................................................................................................................................ 1 0.33 1,620 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address one or more of the following 

points: (1) Evaluate 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) Evaluate 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) Enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) 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, 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 60 days of the date of 

this publication. 

Dated: February 17, 2010. 

Dr. George Nemo, 

NHLBI Project Officer, NHLBI, National 

Institutes of Health. 

[FR Doc. 2010–3754 Filed 2–23–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0067] 

Advisory Committee for 

Pharmaceutical Science and Clinical 

Pharmacology; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Advisory 

Committee for Pharmaceutical Science 

and Clinical Pharmacology. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on March 17, 2010, from 7:30 a.m. 

to 3 p.m. 

Location: Atlanta Marriott Marquis, 

265 Peachtree Center Ave., Atlanta, GA 

30303. The hotel phone number is 404– 

521–0000. 

Addresses: Submit electronic 

comments on this document to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit a 

single copy of electronic comments or 

two paper copies of any mailed 

comments, except that individuals may 

submit one paper copy. Comments 

should be identified with the docket 

number found in brackets in the 

heading of this document. Comments 

received on or before March 8, 2010, 

will be provided to the committee 

before the meeting. Received comments 

may be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Contact Person: Yvette Waples, Center 

for Drug Evaluation and Research (HFD– 

21), Food and Drug Administration, 

5600 Fishers Lane (for express delivery, 

5630 Fishers Lane, rm. 1093), Rockville, 

MD 20857, 301–827–7001, FAX: 301– 

827–6776, e-mail: 

yvette.waples@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512539. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: On March 17, 2010, the 

committee will discuss and provide 

comments on the following topics: (1) 

General scientific issues related to the 

application of pharmacogenomics in the 

early stages of drug development. 

Pharmacogenomics examines the 

genetic differences that influence a 

person’s responses, both beneficial and 

harmful, to certain drugs; (2) a new 

patient-centric clinical pharmacology 

approach to drug safety; (3) the design 

and analysis of clinical pharmacology 

studies focusing on how the renal 

function changes in the way the body 

absorbs, distributes, metabolizes, and 

excretes a drug in patients with kidney 

impairment; and (4) scientific 

considerations and recent developments 

in transporter-mediated drug 

interactions. These interactions are 

between two or more drugs that either 

inhibit or enhance the roles of 

specialized proteins known as 

‘‘transporters’’ and, in turn, the 

interactions can affect a drug’s safety 

and/or efficacy. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before March 8, 2010. Oral 

presentations from the public will be 

scheduled between approximately 9:25 

a.m. and 10 a.m., and 1:15 p.m. and 1:45 

p.m. Those desiring to make formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 


pwalker on DSK8KYBLC1PROD with NOTICES