Federal Register / Vol. 75, No. 84 / Monday, May 3, 2010 / Notices 23265 

request is made on behalf of an 

organization or other entity, the 

signature of a responsible official of the 

organization or other entity. 

ADDRESSES: All documents relating to 

this determination are available for 

inspection between the hours of 8:30 

a.m. and 4:30 p.m., Monday through 

Friday, at the following offices: Alabama 

Department of Environmental 

Management, Drinking Water Branch, 

1400 Coliseum Boulevard, Montgomery, 

Alabama 36130; and the U.S. 

Environmental Protection Agency, 

Region 4, Safe Drinking Water Branch, 

61 Forsyth Street, SW., Atlanta, Georgia 

30303. 

FOR FURTHER INFORMATION CONTACT: Tom 

Plouff, P.E., EPA Region 4, Safe 

Drinking Water Branch, at the address 

given above, by telephone at (404) 562– 

9476, or at plouff.tom@epa.gov. 

Authority: Section 1413 of the Safe 

Drinking Water Act, as amended (1996), and 

40 CFR part 142. 

Dated: April 20, 2010. 

J. Scott Gordon, 

Acting Regional Administrator, Region 4. 

[FR Doc. 2010–10173 Filed 4–30–10; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; Investigating the 

Causes of Post Donation Information 

(PDI): Errors in the Donor Screening 

Process 

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 February 23, 2010, Volume 

75, No. 35, pages 8080–8081 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: 

Investigating the causes of post donation 

information (PDI): Errors in the donor 

screening process. Type of Information 

Collection Request: NEW. Need and Use 

of Information Collection: Blood centers 

are required to use a health history 

screening questionnaire to obtain 

eligibility information for the protection 

of the donor and recipient prior to blood 

donation. However, the health history 

process is known to be error-prone and 

the reasons for those errors are largely 

unknown and untested. Donors often 

fail to report a risk that would have 

resulted in deferral. This deferral risk 

may be disclosed at a subsequent 

donation and is classified as Post 

Donation Information (PDI). While this 

deferral risk may be at the next donation 

event, many examples of PDI are not 

disclosed nor discovered until several 

intervening donation events have 

occurred. The reasons why donors fail 

to disclose a deferrable history at the 

time of one donation but subsequently 

disclose this information at a later time 

are unidentified. This protocol is 

designed to ascertain why PDI error 

events occur. It will be the first study of 

any kind to address the issue of PDI 

errors in any systematic fashion. By 

conducting interviews with donors 

involved in PDI errors, we will gain 

important qualitative knowledge about 

this problem. Information gathered from 

these interviews will not only elucidate 

the issue of PDI but will provide insight 

into donor understanding of the 

screening process and their feelings 

about the process and blood donation in 

general. 

The main objectives of the study are: 

1. To explore reasons behind errors in 

the donor screening process when 

donors initially fail to disclose an 

accurate and complete health history. 

2. To explore PDI donors’ knowledge, 

attitudes, behaviors and beliefs (KABB) 

about the health history questionnaire 

and their experience with the screening 

process and the center. 

3. To compare KABB in PDI donors to 

deferred (but not PDI) donors and 

accepted donors. 

The study sample will consist of three 

groups: 

1. Donors with a PDI: all identified 

donors of interest with an FDA 

reportable donor suitability error 

classified as PDI at the REDS–II centers. 

2. Deferred donors: appropriately 

deferred (but not PDI deferred donors) at 

the REDS–II centers. 

3. Accepted Donors: appropriately 

accepted for donation at the REDS–II 

centers. 

Telephone interviews will be 

conducted with consented donors to 

collect information regarding their 

knowledge, attitudes, behaviors and 

beliefs about the donor health history 

process. Even though the interviews 

with the donors will be individual, we 

would like to form groups of similar PDI 

and deferred donors for analysis 

purposes. 

The five groups of interest include 

PDI occurrences or deferrals that are due 

to: 

• Travel (malaria, vCJD). 

• Medical (history of diseases 

including jaundice/hepatitis, surgery 

and medications needed to treat disease 

including Tegison, Proscar and 

Accutane). 

• Blood/Disease Exposure—(tattoo, 

piercings, accidental needle stick). 

• High Risk Behavior—Sexual (MSM, 

sex with IV drug user or test-positive 

individual). 

• High Risk Behavior—Non-Sexual 

(IV drug use, non-sexual exposure to 

Hepatitis C or Hepatitis B). 

All interviews will be digitallyrecorded and the recordings uploaded 

onto computers as dss files; these files 

will be transcribed and then coupled to 

the interviewer notes to form an analytic 

package for the data analysts. Once the 

interview is conducted successfully, 

each study donor will be mailed a check 

of $25 as an incentive for participating 

in the study. 

The cognitive testing of the interview 

guide will be conducted at the 

Hoxworth Blood Center. For this 

purpose, the blood center staff will 

identify 2 PDI and 2 deferred donors 

from the five broad categories of 

interest. They will also contact 2 

accepted donors for study consent and 

interview. These donors will be 

approached and consented by following 

the same procedures that will be used 

for the actual study. 

The data from the semi-structured 

interviews will be analyzed in two 

ways. The close-ended responses will be 

analyzed quantitatively. This will likely 

take the form of 3-way cross-tabulations 

of frequency distributions in responses 

to key questions. The open-ended 

responses will be analyzed as 

qualitative data. All analytic steps and 

assumptions that led up to the 

conclusions, including competing 

interpretations of the data, will be fully 

discussed in the final report. 

Frequency of Response: Once. 

Affected Public: Individuals. Type of 

Respondents: Adult blood donors. The 

annual reporting burden is a follows: 

Estimated Number of Respondents: 408; 

Estimated Number of Responses per 

Respondent: 1; Average Burden of 

Hours per Response: 0.08 for the initial 

phone call and 0.5 for responding to the 


erowe on DSK5CLS3C1PROD with NOTICES
23266 Federal Register / Vol. 75, No. 84 / Monday, May 3, 2010 / Notices 

actual interview; and Estimated Total 

Annual Burden Hours Requested: 

83.64.The annualized cost to 

respondents is estimated at: $1505.52 

(based on $18 per hour). There are no 

Capital Costs to report. There are no 

Operating or Maintenance Costs to 

report. 

Table 1: Estimate of Requested Burden 

Hours and Dollar Value of Burden 

Hours 

TABLE A.12–1 ESTIMATES OF HOUR BURDEN

Type of respondents No. of respondents 

Estimated number of responses 

per respondent 

Average burden 

hours per response 

Estimated total 

annual burden 

hours requested 

Donors initially contacted ............................................................... 408 1 .08 32 .6 

PDI Donors .................................................................................... *60 1 0.5 30 

Deferred Donors ............................................................................ *30 1 0.5 15 

Accepted Donors ........................................................................... *12 1 0.5 6 

Total ........................................................................................ 408 ............................ ............................ 83 .64 

*These respondents are a subgroup of total 408 donors who will be initially contacted to participate in the study. 

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 361, 6700 

Rockledge Drive, Bethesda, MD 20892, 

or call non-toll-free number 301–435– 

0075, or e-mail your request, including 

your address 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 26, 2010. 

George Nemo, 

Project Officer, NHLBI, National Institutes of 

Health. 

[FR Doc. 2010–10283 Filed 4–30–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

Research and Quality (AHRQ) to request 

that the Office of Management and 

Budget (OMB) approve the proposed 

information collection project: 

‘‘Standardizing Antibiotic Use in LongTerm Care Settings SAUL) Study.’’ In 

accordance with the Paperwork 

Reduction Act, 44 U.S.C. 3501–3520, 

AHRQ invites the public to comment on 

this proposed information collection. 

DATES: Comments on this notice must be 

received by July 2, 2010. 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, by email at doris.lefkowitz@AHRQ.hhs.gov. 

Copies of the proposed collection 

plans, data collection instruments, and 

specific details on the estimated burden 

can be obtained from the AHRQ Reports 

Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477, or by 

e-mail at 

doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Standardizing Antibiotic Use in LongTerm Care Settings (SAUL) 

Study Inappropriate antibiotic 

prescribing practices by primary care 

clinicians caring for residents in longterm care (LTC) communities is 

becoming a major public health concern 

as it is a risk factor for morbidity and 

mortality among LTC residents. 

Antibiotics are among the most 

commonly prescribed pharmaceuticals 

in LTC settings, yet reports indicate that 

a high proportion of antibiotic 

prescriptions are inappropriate. The 

adverse consequences of inappropriate 

prescribing practices are serious and 

include drug reactions/interactions, 

secondary complications, and the 

emergence of multi-drug resistant 

organisms. 

In an effort to reduce antibiotic 

overprescribing, Loeb and colleagues 

developed minimum criteria for the 

initiation of antibiotics in LTC setting 

(Loeb, M., et al. 2001). The criteria have 

been tested in several studies, but their 

implementation and tests of validity 

have been limited. In particular, though 

Loeb and colleagues developed distinct 

minimum criteria for several types of 

infection (skin and soft-tissue, 

respiratory, urinary tract, and 

unexplained fever), a rigorous 

evaluation has been conducted only for 

urinary tract infections. 

Twelve nursing homes (NH) will 

participate in this project; six NHs will 

be recruited to serve as treatment sites 

and six to serve as control sites. Once 

a nursing home community has been 

selected and randomly assigned to the 

treatment or control group, a facility 

recruitment letter will be sent to the 

facility Administrator. The letter will 

include a description of the study and 

inform the Administrator that the 


erowe on DSK5CLS3C1PROD with NOTICES