8080 Federal Register / Vol. 75, No. 35 / Tuesday, February 23, 2010 / Notices 

Dated: Feb. 17, 2010. 

Mara L. Vanderslice, 

Special Assistant. 

[FR Doc. 2010–3559 Filed 2–22–10; 8:45 am] 

BILLING CODE 4154–07–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Investigating the Causes of 

Post Donation Information (PDI): 

Errors in the Donor Screening Process 

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: 

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 

donor 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 and at the 

Coordinating 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 

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 Number 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 

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Federal Register / Vol. 75, No. 35 / Tuesday, February 23, 2010 / Notices 8081 

TABLE A.12–1 ESTIMATES OF HOUR BURDEN—Continued 

Type of respondents Number of respondents 

Estimated number of responses 

per respondent 

Average burden 

hours per response 

Estimated total 

annual burden 

hours requested 

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 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, Room 9144, 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 16, 2010. 

George Nemo, 

NHLBI Project Officer, NHLBI, National 

Institutes of Health. 

[FR Doc. 2010–3449 Filed 2–22–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0585] 

Patrick J. Lais: Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (the act) permanently 

debarring Patrick J. Lais from providing 

services in any capacity to a person that 

has an approved or pending drug 

product application. We base this order 

on a finding that Mr. Lais was convicted 

of a felony under Federal law for 

conduct relating to the regulation of a 

drug product under the act. Mr. Lais has 

notified FDA that he acquiesces to 

debarment, and therefore has waived his 

opportunity for a hearing concerning 

this action. 

DATES: This order is effective February 

23, 2010. 

ADDRESSES: Submit applications for 

special termination of debarment to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kenny Shade, Office of Regulatory 

Affairs (HFC–230), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 240–632–6844. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On April 25, 2005, Mr. Patrick J. Lais, 

formerly president of York 

Pharmaceutical, pleaded guilty to 

introducing and delivering, and causing 

to be introduced and delivered into 

interstate commerce, a drug that was 

adulterated within the meaning of 21 

U.S.C. 351(a)(2)(B) of the act, a felony 

under Federal law in violation of 21 

U.S.C. 331(a) and 333(a)(2). Judgment 

was entered against him for this felony 

on August 15, 2005. The basis for this 

conviction was as follows: 

Beginning in 1997 and lasting until 

September 2001, Mr. Lais was the 

president of York Pharmaceutical 

(York). Mr. Lais had responsibility for 

and authority over drug manufacturing 

at York. York manufactured generic 

over-the-counter drugs during the 

period January 1999 through July 2001. 

York distributed in interstate 

commerce human drug products that 

were adulterated within the meaning of 

21 U.S.C. 351(a)(2)(B) of the act, in that 

York manufactured and distributed, 

among other things, subpotent burn 

spray, aspirin that had failed dissolution 

testing, and antacid products 

contaminated with bacteria. 

Mr. Lais knew that York’s 

manufacturing facility lacked basic 

validation processes and controls and 

that York’s drug products were 

adulterated within the meaning of the 

act. Mr. Lais also knew that York: (1) 

Did not use procedures that ensured 

that its drugs had the identity, strength, 

quality, and purity characteristics that 

they were represented to possess; (2) did 

not test raw materials before using them; 

(3) did not perform appropriate 

laboratory determinations of 

conformance with final specifications 

for each of its drug products; (4) 

shipped drug product known not to 

meet established quality control criteria; 

(5) frequently failed to assess the 

stability characteristics of the drugs it 

produced; (6) did not maintain the 

buildings used in the manufacture, 

processing, packing, and holding of its 

drug products in a clean and sanitary 

condition; and (7) did not clean, 

maintain, and sanitize its manufacturing 

equipment and utensils in such a way 

as to prevent contamination of final 

drug products. 

In January 2000, York manufactured 

and compressed a drug product 

identified as ‘‘Uncoated Aspirin.’’ This 

drug failed its final dissolution testing. 

Neither Mr. Lais nor the employees 

under his authority and control 

determined the cause of the dissolution 

failure. Rather, York coated the failed 

aspirin and renumbered the lot. Part of 

this lot then was packaged as ‘‘Coated 

Aspirin.’’ On or about February 21, 

2000, Mr. Lais caused the shipment of 

625 cases of adulterated drug products, 

identified as ‘‘Coated Aspirin,’’ to 

customers in Kansas City, MO. In May 

2000, this ‘‘Coated Aspirin’’ failed 3– 

month stability testing. Mr. Lais and the 

employees under his authority and 

control did not determine the cause of 

the failure and did not inform York’s 

customers that the aspirin was 

adulterated. 

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