Medical Devices; Patient Examination and Surgeons' Gloves; Test Procedures and Acceptance Criteria; Correction, 2436-2444 [E7-682]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 72, Number 12 (Friday, January 19, 2007)]
[Rules and Regulations]
[Pages 2436-2444]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-682]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 800

[Docket No. 2003N-0056 (formerly 03N-0056)]


Medical Devices; Patient Examination and Surgeons' Gloves; Test 
Procedures and Acceptance Criteria; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
regulation that appeared in the Federal Register of December 19, 2006 
(71 FR 75865). The document issued a final regulation that improves the 
barrier quality of medical gloves marketed in the United States (U.S.). 
The rule will accomplish this by reducing the current acceptable 
quality levels (AQLs) for leaks and visual defects observed during FDA 
testing of medical gloves. By reducing the AQLs for medical gloves, FDA 
will also harmonize its AQLs with consensus standards developed by the 
International Organization for Standardization (ISO) and ASTM 
International (ASTM). The document was published with some errors in 
the use of references. This document corrects those errors.

DATES: This correction is effective on January 19, 2007.

FOR FURTHER INFORMATION CONTACT: Casper E. Uldriks, Office of 
Compliance, Center for Devices and Radiological Health (HFZ-300), Food 
and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 240-
276-0100.

SUPPLEMENTARY INFORMATION: In FR Doc. E6-21591, appearing on page 75865 
in the Federal Register of Tuesday, December 19, 2006, the following 
corrections are made to the SUPPLEMENTARY INFORMATION.
    1. On page 75868, in the second column, section III of the document 
is corrected to read:

``III. Analysis of Impacts

A. Introduction

    FDA has examined the final rule under Executive Order 12866 and the 
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded 
Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 
directs agencies to assess all costs and benefits of available 
regulatory alternatives and,

[[Page 2437]]

when regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety, and other advantages; distributive impacts; 
and equity). The agency believes that this final rule is not a 
significant regulatory action under the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of the 
rule on small entities. Because this final rule will not result in 
economic impacts on domestic small entities, the agency certifies that 
the final rule will not have a significant economic impact on a 
substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act requires that 
agencies prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any Federal mandate 
that may result in the expenditure of State, local and tribal 
governments, in the aggregate, or the private sector of $100,000,000 or 
more (adjusted annually for inflation) in any one year.'' The current 
threshold after adjustment for inflation is $122 million, using the 
most current (2005) implicit price deflator for the Gross National 
Product. FDA does not expect this final rule to result in any 1-year 
expenditure that would meet or exceed this amount.
    The information in the following sections sets forth the bases for 
the previous conclusions. We show the expected annual costs and 
benefits of this final rule next in table 1. The average annualized 
costs of the final rule are estimated to be $6.6 million using either a 
3-percent or 7-percent discount rate. Average annualized benefits are 
expected to be between $14.8 million and $15.1 million, depending on 
the discount rate. Average annualized net benefits are between $8.2 
million and $8.5 million.

    Table 1.--Average Annualized Costs and Benefits (in millions)\1\
------------------------------------------------------------------------
  Annual Discount
        Rate              Costs           Benefits        Net Benefits
------------------------------------------------------------------------
3 Percent            $6.6             $14.8             $8.2
------------------------------------------------------------------------
7 Percent            $6.6             $15.1             $8.5
------------------------------------------------------------------------
\1\Annualized over a 10-year evaluation period.

B. Objective of the Final Rule

    The objective of the final rule is to reduce the risk of 
transmission of blood-borne pathogens (particularly human 
immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) 
infections). The rule accomplishes this objective by ensuring that 
medical gloves (surgeons' and patient examination gloves) maintain a 
high level of quality with respect to the level of noted defects. FDA 
is also harmonizing its level for acceptable defects with consensus 
quality standards developed by ISO and ASTM.

C. Current Risks of Blood-Borne Illness

    Unnecessary exposures to blood-borne pathogens are of great 
importance to the health care community because contact with 
contaminated human blood or tissue products has led to increased cases 
of HIV, HBV, and HCV infections.
    Available data cannot precisely quantify the number of new HIV 
cases that this final rule will prevent. This analysis, however, 
attempts to derive a conservative estimate. For the year 2000, the 
Centers for Disease Control (CDC) reported a cumulative total of 
approximately 900,000 persons in the United States who had contracted 
HIV, of which 775,000 cases had progressed to Acquired Immunodeficiency 
Syndrome (AIDS). Of those patients whose conditions had progressed to 
AIDS, almost 450,000 (58 percent) had died as of December 2000. For the 
year 2000, the CDC identified 21,704 new cases of HIV infection (Ref. 
1).
    Approximately 5 percent of the reported HIV/AIDS cases were among 
health care personnel (Ref. 2). However, in an indepth analysis of 
occupational risk, the CDC reported that between 1992 and 2002 there 
had been 56 identified incidents of occupational transmission of the 
HIV pathogen and all but 7 of these cases (12.5 percent) were due to 
percutaneous cuts or needlesticks. In addition, there were 138 other 
cases of HIV infection or AIDS among health care workers with 
occupational exposures to blood who had not reported other risk factors 
for HIV infection (Ref. 3). Assuming the same 12.5-percent rate for 
these workers implies that 17 additional cases of HIV transmission to 
health care workers during this period might have been caused by 
cutaneous contact in an occupational setting. Consequently, a total of 
24 incidents of occupational transmission of HIV to health care 
personnel may have occurred over the 10-year period (or 2.4 per year) 
due to problems with the barrier protection properties of gloves used 
in health care settings.
    The CDC also reports approximately 80,000 new cases of HBV for the 
latest available reporting period (2001) (Ref. 4). There are 
approximately 1.25 million people in the United States chronically 
infected with HBV. While only 6 percent of those who contract hepatitis 
B after the age of 5 will develop chronic conditions, 15 to 25 percent 
of those that do will die prematurely. Health care personnel are at 
some risk from this pathogen, but the availability of a vaccine has 
reduced the risk of negative outcomes due to exposure. (Ref. 5).
    FDA has no direct data for estimating the rate of new HBV 
infections in health care personnel. While the CDC has reported the 
risk to health care workers as ``low,'' there is no definition of that 
term (Ref. 6). FDA estimates that as many as 4,000, or 5 percent, of 
all new incidents of HBV occur in health care personnel. Because 
occupational transmissions for HBV may be approximately 5 times more 
likely than that for HIV, FDA imputes approximately 140 annual cases of 
occupational transmission of HBV to health care personnel (HIV rate of 
7.3/1,085 x 5 x 4,000). CDC analyses communicate that a large portion 
of HBV infections in health care personnel are the result of direct or 
indirect blood or bodily fluid exposures that inoculated HBV into 
cutaneous scratches, abrasions, burns, other lesions, or on mucosal 
surfaces (Ref. 7). Because 2.4 of the 7.3 annual HIV cutaneous contact 
transmissions (33 percent) were believed to be attributable to glove 
defects, FDA similarly expects about one-third of the 140 annual 
occupational transmissions of HBV infections (approximately 40 cases) 
may potentially be associated with the current quality level of medical 
gloves. If only 6 percent of these cases develop chronic conditions, 
then an average of 2.4 annual cases of chronic HBV are associated with 
defective medical gloves.
    HCV currently infects 3.9 million persons in the United States. 
Over 2.7 million patients have reported chronic conditions. (Ref. 8). 
More than 40,000 new cases were reported in 1999. The risk of exposure 
to health care workers, however, appears to be extremely low. In fact, 
according to the CDC, other than from needle stick punctures, there has 
been no documented transmission of HCV to health care personnel from 
intact or non-intact skin exposures to blood or other fluids or tissues 
(Ref. 9). Thus, there is little evidence that glove defects are 
associated with HCV exposures.
    As a result, FDA estimates the overall annual transmission of 
blood-borne pathogens due to defects in glove barrier protection in 
health care settings to include 2.4 cases of HIV infection and

[[Page 2438]]

2.4 cases of HBV infection. Increasing the AQL of gloves by lowering 
the rate of acceptable defects should reduce the transmission rates of 
these pathogens.

D. Baseline Conditions

    The previous AQL (being replaced by this rule) for medical gloves 
allowed a defect rate of 4.0 percent for patient examination gloves and 
2.5 percent for surgeons' gloves. The AQL represents the proportion of 
sampled gloves from a given lot that may include defects such as leaks 
or foreign material and still be accepted for entry into the 
marketplace. Currently, if more than 4 percent of the sampled patient 
examination gloves exhibit defects in accordance with the sampling 
criteria, the entire lot of gloves is considered adulterated. Surgeons' 
gloves are sampled to a higher quality level (lower AQL requires a 
higher proportion of non-defective gloves in order to pass inspection), 
because these products have a higher likelihood of contact with bodily 
fluids. Of course, medical glove lots that fail to meet the AQL may be 
marketed as household or other products. If a sample of gloves fails to 
meet the AQL, the marketer may request resampling of the lot. The 
required sampling plan for a lot originally found to be out of 
compliance is more intensive than the original sampling plan for a 
randomly selected lot. Lots initially found to be out of compliance are 
either resampled and subsequently offered as medical devices after 
meeting the current AQL, offered as nonmedical gloves, or sold in 
foreign markets.
    Approximately 39.5 billion medical gloves were imported into the 
United States during 2004 (Ref. 10). According to FDA records, there 
are over 400 manufacturers of medical gloves. Malaysian manufacturers 
supply almost 40 percent of the medical gloves in the United States 
while Thailand manufacturers supply approximately 30 percent (Ref. 11). 
Surgeons' gloves accounted for only about 15 percent of all imported 
medical gloves during 2004, and the impact of the final rule on this 
sector is negligibly different from overall patient examination gloves. 
Therefore, this analysis focuses exclusively on patient examination 
gloves.
    FDA expects the demand for medical gloves to increase by the same 
rate as employment in the medical services industry. The Bureau of 
Labor Statistics has projected annual employment growth of 2.6 percent 
for this industry (North American Industry Classification System 6200) 
(Ref. 12), which implies an annual volume of over 50 billion medical 
gloves in 10 years. (A 2.6 annual growth rate results in an expected 
increase of 29.3 percent in 10 years.)
    Medical glove lot sizes may vary from as few as 25 gloves to as 
many as 500,000. According to discussions with manufacturers (Eastern 
Research Group, Inc. (ERG), 2001), a typical production or import lot 
from a foreign manufacturer contains an average of 325,000 gloves 
(either patient examination or surgeons'). This implies that the U.S. 
medical glove market currently imports over 120,600 lots of gloves per 
year. FDA currently samples only about 1.5 percent of all glove lots, 
or 1,800 lots per year. Within 10 years, FDA expects the number of lots 
offered for import to increase to 156,000. If the compliance sampling 
rate remains constant, FDA would sample about 2,300 lots during that 
year.
    FDA's Winchester Engineering and Analytical Center (WEAC) analyzed 
results from samples collected from 2000 and 2001. These samples 
represent approximately one-third of FDA's total sampling effort for 
the period. (Ref. 13). A total of 98,067 gloves were tested from 942 
separate lots. Of these gloves, 2,354 were defective, which implies 
that 2.4 percent of marketed gloves are likely to be defective. (Ref. 
14) If so, then approximately 940 million defective medical gloves are 
currently marketed (39.2 billion gloves x 0.024). At the current AQL of 
4.0, 28 lots (2.97 percent) failed. Consequently, approximately 53 
annually sampled lots are defective (1,800 sampled lots x 0.0297). By 
the 10th year, in the absence of the final regulation, 1.21 billion 
defective gloves would be marketed and 68 of the sampled lots would 
fail to meet the AQL.
    FDA allows glove lots that fail to meet the AQL to be resampled. 
Sponsors usually attempt to resample the glove lot rather than divert 
the entire lot to alternative markets. According to discussions with 
industry sources and testing laboratories, the cost of glove lot 
resampling and retesting for leakage and tensile strength is 
approximately $1,400. The current annual industry cost of resampling 
glove lot failures with the current AQL is approximately $74,000 (53 
lots times $1,400 per lot). This resampling and retesting cost would 
equal $95,000 within 10 years.

E. Costs of the Final Rule

    FDA expects that the final rule will result in changed shipping 
practices by medical glove manufacturers. Currently, manufacturers use 
the target AQLs as a guide for releasing production lots of gloves for 
export to the United States because the release criteria are lower in 
the United States than in other markets. Manufacturers attempt to avoid 
having three failures within a 24-month period, because this may result 
in refusal of future imports under Level 3 detention described in FDA's 
current policy, ``Surveillance and Detention Without Physical 
Examination of Surgeon's and/or Patient Examination Gloves.'' Thus, to 
maintain an uninterrupted supply of gloves to customers, and to guard 
brand loyalty while avoiding Level 3 detention, manufacturers would be 
expected to raise their level of quality control to at least maintain 
the current average lot rejection rate of 2.97 percent. FDA also 
expects the rule to increase the costs of sampling by requiring larger 
and more detailed sampling plans to assure the lower AQL is met for 
each inspected glove lot. FDA does not envision increased regulatory 
oversight costs because the rate of inspections is not expected to 
change. Costs have been analyzed and discounted using the methodology 
suggested by the Office of Management and Budget's (OMB's) Circular A-4 
(September 2003).
1. Costs of Quality Control
    Manufacturers currently conduct quality control tests on glove lots 
prior to release. These tests include water-tight leak and tensile 
strength assays. According to interviews with glove manufacturers, the 
current cost of conducting these tests at the manufacturing site is 
approximately $310 per lot, while the more stringent quality control 
testing required by this rule may cost an additional $45 per lot. The 
additional cost is for increased inventory and larger sample sizes to 
ensure more precise measurements at the lower AQL. Because 
approximately 120,600 lots are currently imported per year, the 
expected costs are $5.4 million (120,600 lots x $45 per lot). The 
expected increase in the demand for medical gloves by the 10th 
evaluation year will result in a compliance cost of meeting this 
increased quality level of $7.0 million. Over the 10-year period, the 
average annualized cost of this increased level of testing, at a 3-
percent annual discount rate, is $6.2 million and, at a 7-percent 
annual discount rate, is $6.2 million.
2. Increased Sampling Costs
    A lower AQL will result in increased sampling costs for imported 
glove lots. The increased sampling costs will result from the need to 
test greater quantities of gloves in order to ensure sufficient 
statistical power. Based on reported costs from U.S. testing 
laboratories, ERG, an independent economic contractor, estimated that 
increased

[[Page 2439]]

testing would add approximately $200 to the current costs of $1,400 per 
sample. (The difference between this increased cost and the $45 
increased quality control cost is attributable to lower costs in 
foreign countries that produce medical gloves.) FDA currently samples 
about 1.5 percent of the 120,600 lots imported annually, or 1,800 
samples. Thus, the increased sampling costs due to this final rule are 
$0.4 million (120,600 lots x 0.015 x $200). Within 10 years, this 
increased cost will equal $0.5 million (due to expected increases in 
the number of inspected glove lots). The average annualized sampling 
cost increase at a 3-percent annual discount rate is $0.4 million, and 
at a 7-percent annual discount rate is $0.4 million.
3. Withheld Lots
    The lower AQL in this final rule is also likely to result in an 
increase in the number of lots of medical gloves that are not released 
for shipment to the U.S. medical market. For example, manufacturers may 
attempt to maintain a target compliance level in order to avoid FDA's 
Level 3 detention under ``Surveillance and Detentions Without Physical 
Examination of Surgeon's and or Patient Examination Gloves.'' FDA's 
WEAC laboratory sampled 942 lots and discovered that 28 failed using 
the current AQL while 79 lots failed using the lower AQL in this final 
rule. (Ref. 15) To maintain the original 0.0297 (28/942) lot failure 
rate, the 53 lots with the highest defect rate would have to be held 
back by the affected manufacturers (.056)\1\.
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    \1\The current lot failure rate (28/942 = 0.0297) is reached by 
removing 53 defective lots from the sample. If only the 51 
additional failing lots are removed, the overall failure rate is 
0.0314 (28/891). The expected future failure rate is 0.0292 (26/
889). FDA expects the withheld lots to include those with the 
highest defect rates.
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    Therefore, FDA anticipates that under the lower AQL in the final 
rule, approximately 6,900 lots will be held back by manufactures. In 
order to meet the expected demand in 10 years, FDA expects that 9,000 
lots will be held back. FDA believes that glove lots that fail to meet 
the lower AQL in this final rule for medical quality standards will 
most likely be sold as nonmedical gloves. FDA believes that, although 
manufacturers and distributors may experience some loss of revenue from 
this shift (because of the price premium commanded by medical gloves), 
the loss will be inconsequential.
4. Costs of FDA Inspections
    FDA does not envision increased inspection costs due to the final 
rule. The rate of sampled glove lots is not expected to differ and FDA 
resources are not expected to increase over the evaluation period.
5. Total Costs
    In sum, FDA estimates that the final rule will have an average 
annualized cost of about $6.6 million using either a 3-percent or 7-
percent annual discount rate. Table 2 of this document presents the 
costs for each year of the evaluation period.

        Table 2.--Costs per Year of the Final Rule (in millions)
------------------------------------------------------------------------
                  Costs for Quality      Costs for
      Year             Control            Sampling         Total Costs
------------------------------------------------------------------------
Current          $5.4                $0.4               $5.8
------------------------------------------------------------------------
1                $5.6                $0.4               $6.0
------------------------------------------------------------------------
2                $5.7                $0.4               $6.1
------------------------------------------------------------------------
3                $5.9                $0.4               $6.3
------------------------------------------------------------------------
4                $6.0                $0.4               $6.4
------------------------------------------------------------------------
5                $6.2                $0.4               $6.6
------------------------------------------------------------------------
6                $6.3                $0.4               $6.7
------------------------------------------------------------------------
7                $6.5                $0.4               $6.9
------------------------------------------------------------------------
8                $6.7                $0.4               $7.1
------------------------------------------------------------------------
9                $6.8                $0.5               $7.3
------------------------------------------------------------------------
10               $7.0                $0.5               $7.5
------------------------------------------------------------------------
Present Values   3%-$53.2            3%-$3.6            3%-$56.8
                 7%-$43.4            7%-$2.9            7%-$46.3
------------------------------------------------------------------------

F. Benefits of the Rule

    The final rule will result in public health gains by reducing the 
frequency of blood-borne pathogen transmissions due to defects in the 
barrier protection provided by medical gloves. Based on an implied 
societal willingness to pay (WTP), FDA expects that an annualized 
monetary benefit of $14.8 million (using a 3-percent discount rate) or 
$15.1 million (using a 7-percent discount rate) will be realized due to 
fewer pathogen transmissions and unnecessary blood screens. Fewer glove 
defects will reduce the cost and anxiety associated with unnecessary 
blood screens (i.e., those that would yield negative results for health 
care personnel). Benefits have been analyzed and discounted using the 
methodology suggested by OMB's Circular A-4 (September 2003).
1. Reductions in the Number of Marketed Defective Gloves
    As noted in the previous paragraphs, FDA has determined that 
approximately 940 million defective gloves are marketed each year in 
the United States, or 2.4 percent of all medical gloves. In the absence 
of this rule, FDA expects that the number of defective medical gloves 
marketed in the United States would increase to 1.21 billion per year 
within 10 years. The final rule will substantially reduce this figure.
    WEAC's analysis of 98,067 medical gloves from 942 sampled lots 
collected in 2000 and 2001 resulted in approximately 3-percent lot 
failures with an AQL of 4.0 (28 lots would fail). This lot failure rate 
was associated with 2,356 defective gloves, or 2.4 percent of the total 
number of sampled gloves. (Ref. 16). Under the lower AQL of 2.5 in the 
rule, the WEAC analysis concluded that 51 additional lots would fail (a 
total of 79 failed lots), increasing the lot failure rate from 2.91 
percent to 8.39 percent.
    As previously mentioned, FDA provides a Level 3 detention status in 
its guidance, ``Surveillance and Detentions Without Physical 
Examination of Surgeon's and or Patient Examination Gloves.'' 
Manufacturers on Level 3 detention are not allowed to import medical 
gloves because they have repeatedly failed analysis. To avoid the 
denial of entry, manufacturers may be expected to hold a sufficient 
number of defective lots from shipment in order to maintain the same 
target lot failure rate (approximately 3 percent) with a new AQL. If 
so, removing the 53 most defective lots in the testing sample would 
result in 26 lot failures from 880 total lots, thereby maintaining the 
original 2.92 percent lot failure rate. This scenario leaves 85,172 
total gloves in the sample, of which 1,512 were defective, resulting in 
a glove defect rate of 1.78 percent. The final rule, therefore, could 
reduce the proportion of marketed defective medical gloves from 2.4 
percent of all marketed gloves to 1.78 percent of all marketed gloves.
    The implications of this expected reduction in defective gloves are 
significant. The current AQL is associated with 940 million glove 
defects during the present year (based on 2004) and within 10 years 
would result in 1.21 billion marketed defective medical gloves. When 
the lower AQL is in place, the current number of defective gloves will 
approximate 700 million and within 10 years will result in 900 million 
defective marketed gloves. The number of defective gloves,

[[Page 2440]]

therefore, should be reduced by more than 25 percent due to the new 
AQL.
2. Reductions in Blood-Borne Pathogens
    FDA has estimated that there are potentially 4.8 annual 
transmissions of blood-borne pathogens associated with medical glove 
defects (section III.C of this document). These transmissions include 
2.4 cases of HIV and 2.4 cases of chronic HBV. Because there are 
currently no documented cases of cutaneous transmission of HCV that 
would be affected by improving glove quality levels, this analysis does 
not consider potential HCV transmission.
    a. Reductions in HIV transmission. While the direct relationship 
between defective medical gloves and the transmission of HIV is 
unknown, FDA believes it is reasonable to apply the proportional 
reduction in the number of defective gloves due to the final rule 
(about 25 percent) to the annual transmission rate of the HIV pathogen 
to health care personnel. In the absence of this rule, the current 
expectation of 2.4 annual cases of HIV transmission to health care 
personnel would likely increase to 3.1 annual cases within 10 years due 
to the expected growth of employment in the health services industry. 
However, with the new AQL in place, FDA forecasts the expected annual 
transmission of HIV to health care personnel to equal 1.8 cases in 
current conditions and 2.3 cases by the 10th evaluation year (based on 
the expected proportionate decrease in marketed defective gloves). Over 
the entire 10-year evaluation period, these assumptions suggest that 
the rule should prevent approximately seven cases of HIV transmission 
to health care personnel.
    b. Reductions in HBV transmissions. Hepatitis B transmissions to 
health care personnel are more common than cutaneous HIV transmissions. 
However, little specific data are available to identify affected 
patient populations and routes of transmission. FDA has estimated that 
as many as 2.4 cutaneous transmissions of chronic HBV may be due to 
defective medical gloves each year. In the absence of this rule, this 
number would be expected to increase to 3.1 annual transmissions within 
10 years, based on the expected employment growth in the health 
services industry.
    Implementation of the final rule should decrease these 
transmissions by about 25 percent. FDA expects 1.8 HBV transmissions 
under current conditions, a reduction of 0.6 transmissions from 
baseline conditions. By the 10th evaluation year, FDA expects that 
there will be 2.3 chronic HBV transmissions with the lower AQL, or a 
total of 0.8 fewer cases. Overall, about 7 transmissions of chronic HBV 
will be avoided due to the final rule over a 10 year evaluation period.
3. Reductions in the Number of Blood Screening Tests
    As the number of defective gloves marketed in the United States 
decreases due to this rule, corresponding reductions would be expected 
in the number of unnecessary blood screens. FDA contacted several 
research hospitals to ascertain how frequently health care personnel 
identify glove failure as a reason for initiating blood screens. 
Respondents stated that about 5-percent of all glove failures are 
noticed by the user and about 1 percent of these identified failures 
are reported to the facility for additional screening (Ref. 17). 
Respondents noted that the glove failure could occur prior to patient 
contact. Therefore, the additional screening may apply to the affected 
health care personnel or the patient. The great majority of these 
screens result in negative findings.
    As shown in the previous paragraphs, when the final rule is in 
effect, FDA expects the number of defective gloves marketed to decrease 
from 940 million to 700 million, a reduction of 240 million defective 
gloves. By the 10th year, the number of defective gloves is expected to 
decrease from 1.21 billion to 900 million, a reduction of 310 million 
defective gloves. At the rates of potential identification (5 percent) 
and reports of contact with pathogens (1 percent) obtained from the 
research hospital sector, the final rule should result in 120,000 fewer 
unnecessary blood screens under current conditions (240 million fewer 
defects x 0.05 x 0.01). By the 10th year, 155,000 fewer annual blood 
screens are expected. Over the entire evaluation period, the rule could 
result in over 1.4 million fewer unnecessary blood screens.
4. Cost-Effectiveness of the Final Rule
    We analyzed the cost-effectiveness of the final rule using both the 
cost per transmission of blood-borne pathogen avoided and the cost per 
unnecessary blood screen avoided. The annual numbers of future avoided 
transmissions and tests were compared to the present values of the 
costs for the evaluation period and shown in table 3. Table 3 of this 
document shows the expected annual reductions in blood-borne pathogens 
and unnecessary blood screens due to the final rule.

      Table 3.--Expected Annual Reductions in Blood-Borne Pathogen
               Transmissions and Unnecessary Blood Screens
------------------------------------------------------------------------
                                                       Reduction in
         Year           Reduction in Blood-Borne     Unnecessary Blood
                          Pathogen Transmission           Screens
------------------------------------------------------------------------
Current                 1.2                       120,000
------------------------------------------------------------------------
1                       1.2                       120,000
------------------------------------------------------------------------
2                       1.2                       125,000
------------------------------------------------------------------------
3                       1.4                       135,000
------------------------------------------------------------------------
4                       1.4                       135,000
------------------------------------------------------------------------
5                       1.4                       140,000
------------------------------------------------------------------------
6                       1.4                       145,000
------------------------------------------------------------------------
7                       1.6                       150,000
------------------------------------------------------------------------
8                       1.4                       145,000
------------------------------------------------------------------------
9                       1.6                       155,000
------------------------------------------------------------------------
10                      1.6                       155,000
------------------------------------------------------------------------

    Although these reductions should continue beyond the evaluation 
period, we have analyzed only through the 10th year. Each year's 
expected number of reduced blood-borne pathogen transmissions and 
unnecessary blood screens are discounted (using both a 3-percent annual 
discount rate and a 7-percent annual discount rate) to arrive at an 
equivalent number of reductions if valued during the first evaluation 
year. The present values of the regulatory costs (shown in table 4 of 
this document) are divided by the present values of the expected 
reductions to arrive at the cost per avoided event. This is shown in 
table 4 of this document.

[[Page 2441]]



         Table 4.--Regulatory Cost-Effectiveness per Incidence of Blood-Borne Pathogen Transmission Avoided and Unnecessary Blood Screen Avoided
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                          Present Value of                             Cost per Blood-Borne
          Annual Discount Rate               Costs (in      Present Value of Blood-    Pathogen Avoided (in    Present Value of Blood    Cost per Blood
                                             millions)      Borne Pathogens Avoided         millions)             Screens Avoided        Screen Avoided
--------------------------------------------------------------------------------------------------------------------------------------------------------
3 percent                                            $56.8                     12.2                     $4.7                1,191,000                $48
--------------------------------------------------------------------------------------------------------------------------------------------------------
7 percent                                            $46.3                      9.8                     $4.7                  971,000                $48
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The cost-effectiveness of the final rule is $4.7 million per 
transmission of blood-borne pathogen avoided, or $48 per unnecessary 
blood screen avoided for both discount rates. We note that both 
reductions should occur and the allocation of costs to each outcome 
would reduce the costs per avoided event for both.
5. Value of Avoiding Blood-Borne Pathogens
    a. Quality adjusted life-years. The economic literature includes 
many attempts to quantify societal values of health. A widely cited 
methodology assesses wage differentials necessary to attract labor to 
riskier occupations. This research indicates that society appears to be 
WTP approximately $5 million to avoid the probability of a statistical 
death (Ref. 18). That is, social values appear to show that people are 
WTP a significant amount to reduce even a small risk of death; or 
similarly, to demand significant payments to accept marginally higher 
risks.
    Because this estimate is predominantly based on blue-collar 
occupations that mainly attract males between the ages of 30 and 40, 
FDA adjusted the life-expectancy of a 35-year-old male to account for 
future bed and non-bed disability (Ref. 19), and amortized the $5 
million (at both 3-percent and 7-percent discount rates) over the 
resulting quality-adjusted life span. The results were estimates of 
$213,000 per quality adjusted life-year (QALY) using a 3-percent 
discount rate and $373,000 per QALY using a 7-percent discount rate, 
which implies that society is WTP between $213,000 and $373,000 for the 
statistical probability of a year of perfect health, depending on the 
discount rate.
    b. Value of morbidity losses. In theory, loss of health reduces the 
WTP for additional longevity. Many studies have attempted to estimate 
the relative loss of health for many different conditions of morbidity. 
One method utilizes the Kaplan-Bush Index of Well-Being. This index 
assigns relative weights to functional states, and then adjusts the 
resulting weighted value by the problem/symptom complex that 
contributed to loss of function (Ref. 20). Functional state is measured 
in three areas: Mobility, social activity, and physical activity. For 
example, with most treatment, chronic HBV is unlikely to have a major 
impact on any of these functions; a patient could drive a car, walk 
without a physical problem, and conduct work, school, housework and 
other activities. However, because a patient with HBV has an ongoing 
problem/symptom complex, the relative weight of this functional state 
is 0.7433\2\. (Ref. 21).
---------------------------------------------------------------------------

    \2\The implication is that an ideal health state is valued as 
1.0000 and mortality at 0.0000. Each functional state between these 
extremes is a proportionate value of ``perfect'' health.
---------------------------------------------------------------------------

    This methodology then adjusts the weighted value of the functional 
state by the most severe problem/symptom complex contributing to that 
state. In the case of chronic HBV, the most common symptom is general 
tiredness, weakness, or weight loss. This complex has a derived 
relative weight of +0.0027, which when added to the weighted functional 
state value results in a relative weight of 0.7460. The loss of 
relative health due to HBV, therefore, is expected to equal 1.0000 
minus 0.7460, or 0.2540 of perfect health. When this relative health 
loss is applied to the derived value of a QALY, it implies that society 
would be WTP between $54,000 (3 percent) and $93,000 (7 percent) per 
year to avoid a case of HBV (QALY value x 0.2540). This value includes 
the potential costs of treatment and additional prevention, as well as 
any perceived pain and suffering.
    FDA compared this methodology to a variety of published estimates 
of preference ratings of morbidity prepared by the Harvard Center for 
Risk Analysis (HCRA). The published ratings of 14 studies of chronic 
HBV ranged from 0.75 to 1.00 (no impact) (Ref. 22). While the estimate 
used in this analysis (0.746) is in the low end of collected published 
studies, FDA notes that most of the expressed preferences that were 
derived from time trade-off and standard gamble methodologies, as 
compared to author judgment, were closer to the FDA estimate. A health 
care worker who may contract HBV may typically have a life expectancy 
of approximately 40 years (as of the year 2000, a 40-year-old female 
had a future life expectancy of 41.1 years (Ref. 23)). The present 
value (PV) of $54,000 (3 percent) and $93,000 (7 percent) for 40 years 
implies that society is WTP $1.25 million (3 percent) or $1.24 million 
(7 percent) to avoid the statistical likelihood of a case of chronic 
HBV in health care personnel.
    Deriving society's implied WTP to avoid HIV is more complicated. 
The CDC has published data indicating that approximately 80 percent of 
all HIV infections progress to AIDS within 5 years. Of the cases of 
AIDS, over half (approximately 60 percent) result in mortality within 
an additional 5 years. Thus, for a 10 year period, FDA tracked 3 
potential outcomes: Patients who contract HIV but do not progress to 
AIDS (20 percent), patients who contract HIV and progress to AIDS in 5 
years and survive (32 percent), and patients who contract HIV, progress 
to AIDS within 5 years and then die within an additional 5 years (48 
percent).
    HIV infection is not expected to affect either mobility or social 
activity. However, such an infection is likely to somewhat inhibit 
physical activity. HIV patients are expected to be able to walk, but 
with some physical limitations. This functional state has a relative 
weight of 0.6769. The main problem/symptom complex of HIV is general 
tiredness (as for HBV), so the selected functional weight is adjusted 
by +0.0027 to result in relative well-being of 0.6796. As a result, the 
relative societal WTP to avoid the statistical probability of a case of 
HIV in health care personnel is approximately $68,000 (3 percent) or 
$120,000 (7 percent) per year (QALY value x (1.0000 minus 0.6796)). 
According to the collected preference scores in the HCRA's Catalog of 
Preference Scores, the average estimated published preference rating 
for HIV infection was 0.7 (range 0.3 to 1.00). (Ref. 24).
    If HIV progresses to AIDS, a patient's functional state is likely 
to be more restricted. An AIDS patient requires some assistance with 
transportation, is limited in physical activity, and is limited in 
work, school, or household

[[Page 2442]]

activity. The relative weight for this functional state is 0.5402. The 
main problem/symptom of AIDS remains general tiredness and loss of 
weight (as with HIV and HBV), so the adjusted health state is 0.5429. 
This results in a derived societal WTP to avoid the statistical 
probability of a case of AIDS of about $97,000 (3 percent) or $170,000 
(7 percent) per year (QALY value x (1.0000 minus 0.5429)). The HCRA's 
Catalog of Preference Scores reports average preference ratings of 
0.375 for cases of AIDS with ranges from 0.0 to 0.5. (Ref. 25).
    As discussed earlier, the derived societal WTP to avoid a 
statistical mortality has been estimated to equal approximately $5 
million.
    Using these estimates, the WTP to avoid the statistical probability 
of an HIV transmission in health care personnel is calculated as the 
sum of:
     20 percent of the PV (at 3-percent and 7-percent discount 
rates) of avoiding 40 years of HIV infection.
     32 percent of the sum of the PV of avoiding 5 years of a 
HIV infection plus the PV of avoiding 35 years of AIDS infection 
occurring 5 years in the future.
     48 percent of the sum of the PV of avoiding 5 years of HIV 
infection plus the PV of avoiding 5 years of AIDS infection occurring 5 
years in the future plus the discounted WTP of avoiding a statistical 
mortality occurring 10 years in the future.
    The PV of avoiding 40 years of health loss valued at $68,000 per 
year (3 percent) is approximately $1.6 million and if valued at 
$120,000 per year (7 percent) is also approximately $1.6 million. 
Twenty percent of this figure equals $320,000.
    The PV of avoiding 5 years of health loss to due HIV infection is 
equal to $311,000 (3 percent) or $492,000 (7 percent). The PV of 
avoiding the health loss expected from 35 years of AIDS infection 
(valued at $97,000 (3 percent) and $170,000 (7 percent) per year) is 
equivalent to $2.1 million (3 percent) and $2.2 million (7 percent). 
The present values of these amounts occurring 5 years in the future are 
$1.8 million (3 percent) and $1.6 million (7 percent). When added to 
the PV of avoiding the health loss associated with 5 years of HIV 
infection ($311,000 (3 percent) and $492,000 (7 percent)), the total 
estimated PV of the societal WTP to avoid a statistical case of this 
outcome is about $2.1 million (for both 3-percent and 7-percent 
discount rates). Thirty-two percent of this figure equals $660,000.
    The PV of avoiding the health loss associated with 5 years of AIDS 
infection ($445,000 (3 percent) and $700,000 (7 percent)) occurring 5 
years in the future is equivalent to $384,000 (3 percent) and $497,000 
(7 percent). The PV of the societal value of avoiding a statistical 
mortality ($5 million) 10 years in the future is $3.72 million (at 3 
percent) and $2.54 million (at 7 percent). The total societal WTP to 
avoid a case of HIV with mortality as an outcome, therefore, is $4.4 
million using a 3-percent discount rate ($311,000 plus $384,000 plus 
$3.72 million) and $3.5 million using a 7-percent discount rate 
($493,000 plus $497,000 plus $2.54 million). Forty-eight percent of 
these figures equals approximately $2.1 million (3 percent) and $1.7 
million (7 percent).
    Summing the weighted amounts of the three expected outcomes for a 
case of HIV infection equals an estimated societal WTP of $3.08 million 
using a 3-percent discount rate ($320,000 plus $660,000 plus $2.1 
million) and $2.68 million using a 7-percent discount rate ($320,000 
plus $660,000 plus $1,700,000).
    In sum, the estimated societal values of avoiding morbidity and 
mortality due to transmission of blood-borne pathogens are estimated to 
be equivalent to $1.25 million per transmission of chronic HBV and 
$3.08 million per transmission of HIV using a 3-percent discount rate 
and $1.24 million per transmission of HBV and $2.68 million per 
transmission of HIV using a 7-percent discount rate. FDA notes that 
other cost-effectiveness research has determined cost-effectiveness 
estimates (excluding pain and suffering) of $2.1 million per avoided 
case of HIV. (Ref. 26).
    FDA believes the methodology used to estimate the value of avoided 
HBV and HIV infection is reasonable and supportable. However, 
comparative methodologies that demonstrate both higher and lower values 
on avoidance have been reported. FDA acknowledged these differences in 
the proposed rule and solicited comment on other appropriate measures 
for estimating the societal value of avoiding blood-borne pathogens. 
FDA received no responses.
    c. Benefit of morbidity avoidance. The rule is expected to reduce 
both HBV and HIV transmissions by reducing the prevalence of defective 
medical gloves used as barrier protection. During the first evaluation 
year, the rule is expected to result in 0.6 fewer chronic HBV 
transmissions to health care personnel. Applying the assumed societal 
WTPs of $1.25 million (3 percent) and $1.24 million (7 percent) to 
avoid the probability of an HBV infection, the expected benefit of 
avoiding these transmissions is $0.8 million (3 percent) and $0.7 
million (7 percent). By the 10th evaluation year, 0.8 annual 
transmissions are expected to be avoided at a value of $1.0 million for 
either discount rate. The PV of avoiding approximately 7 chronic HBV 
transmissions over a 10-year period equals $7.6 million (at 3-percent 
discount rate) and $6.1 million (at 7-percent discount rate). This is 
equal to an average annualized value of $0.9 million for the entire 10-
year evaluation period at either discount rate.
    Also, in the first evaluation year, FDA expects that the final rule 
will result in the probability of 0.6 fewer transmissions of HIV caused 
by defective gloves. Assuming that society is WTP $3.08 million (at 3-
percent discount rate) and $2.68 million (at 7-percent discount rate) 
to avoid the probability of a single HIV transmission, the benefit of 
avoiding these transmissions equals $1.8 million (3 percent) and $1.6 
million (7 percent). By the 10th evaluation year, FDA expects the final 
rule to result in 0.8 fewer HIV transmissions, which are valued at $2.5 
million (3 percent) and $2.1 million (7 percent). The societal PV of 
avoiding seven transmissions of HIV over the 10-year evaluation period 
is $18.8 million (at 3-percent discount rate) and $13.1 million (at 7-
percent discount rate). These values are equivalent to average 
annualized benefits of $2.2 million (at 3-percent discount rate) and 
$1.9 million (at 7-percent discount rate).
    In sum, FDA estimates that the reduction in blood-borne pathogen 
transmissions due to this final rule should produce health benefits 
valued at $3.1 million (at 3-percent discount rate) and $2.8 million 
(at 7-percent discount rate) per year. Most of this benefit (over 67 
percent) is attributable to reducing the incidence of HIV.
6. Value of Avoiding Unnecessary Blood Screens
    The expected decline in the number of defective medical gloves 
should lead to fewer unnecessary blood screens and thereby provide two 
potential benefits. First, the direct cost of conducting screens to 
determine whether the pathogen was transmitted to health care personnel 
should decrease. Second, the psychological anxiety and stress that 
accompanies the possibility that a pathogen was transmitted to an 
individual should also decrease.
    a. Cost of conducting blood screens. FDA has collected data from 
the American Red Cross on the costs of conducting blood screening tests 
in order to ensure the safety of the blood supply. These estimates 
include the costs of collection (including personnel,

[[Page 2443]]

needles, bags, and other supplies) at $47.66 per sample; sample testing 
at $25.16 per sample; and overhead at $3.26 per sample. The estimated 
direct testing cost per blood sample is the sum of these amounts, or 
$76 per test (Ref. 27).
    b. Anxiety and stress associated with potential transmission of 
pathogens. The psychological literature has noted that levels of 
anxiety and stress impact participation in public health screening 
programs and thereby affect physiological health (Ref. 28). Also, 
patients with high levels of uncertainty about whether they have 
contracted serious, threatening diseases experience heightened levels 
of stress and anxiety until they learn the results of any testing 
screens are negative (Ref. 29). According to one measurement scale of 
well-being, reduced mental lucidity, depression, crying, lack of 
concentration, or other signs of adverse psychological sequelae may 
detract as much as 8-percent from overall feelings of well-being and 
have outcomes similar to physiological morbidity (Ref. 30). Scaling of 
the relative stress caused by events shows that concerns about personal 
health, by themselves, are likely, on average, to contribute 
approximately one-sixth of the total weighting required to trigger a 
major stressful episode (Ref. 31). Thus, FDA approximates that 
increased stress and anxiety concerning possible exposure to pathogens 
may reduce overall sense of well-being and result in health loss of 
approximately 1.3 percent (0.013).
    As described earlier, FDA has calculated an assumed WTP of $213,000 
(at 3 percent) and $373,000 (at 7 percent) for a statistical QALY. 
These figures imply that the probability of each day of quality 
adjusted life has a social value of about $585 (at 3-percent discount 
rate; $213,000 divided by 365) and $1,020 (at 7-percent discount rate; 
$373,000 divided by 365). If blood test results are usually obtained 
within 24 hours, the resultant loss of societal well-being for each 
test subject is valued at approximately $8 (at 3-percent discount rate; 
$585 x 0.013) and $13 (at 7-percent discount rate, $1,020 x 0.013).
    c. Benefit of test avoidance. By combining avoided direct costs of 
tests and the value of avoided anxiety and stress, FDA estimates that 
the societal benefit of avoiding an unnecessary blood test is $84 per 
sample (at 3-percent discount rate) and $89 per sample (at 7-percent 
discount rate). During the first evaluation year, FDA expects that 
there will be 120,000 fewer unnecessary blood screens because of the 
expected reduction in defective medical gloves due to the final rule. 
The implied societal WTP to avoid these unnecessary screens is $10.1 
million (3 percent) and $10.7 million (7 percent). During the 10th 
evaluation year, approximately 155,000 fewer unnecessary blood screens 
are expected with a resultant benefit of $13.0 million (3 percent) and 
$14.0 million (7 percent). The PV of each year's reduced cost of 
testing and anxiety totals $100.0 million (at 3-percent discount rate) 
and $86.4 million (at 7-percent discount rate). The average annualized 
equivalent amounts are $11.7 million (3 percent) and $12.3 million (7 
percent). Between 85 percent and 90 percent of the average annualized 
amounts represent reductions in the direct testing costs rather than 
the reduced anxiety associated with possible infection by a contagious 
agent.
7. Total Benefits
    FDA estimates that the final rule will reduce the availability of 
defective medical gloves by over 25 percent, resulting in over 2.8 
billion fewer defective gloves over a 10-year period. During this time, 
FDA expects that the reduction in defective gloves will result in 
approximately 7 fewer cases of chronic HBV, 7 fewer cases of HIV, and 
1.4 million fewer unnecessary blood screens. Based on an implied 
societal WTP, the average annualized benefits of the fewer pathogen 
transmissions and unnecessary blood screens should equal $14.8 million 
(at 3-percent annual discount rate) and $15.1 million (at 7-percent 
discount rate).

G. Conclusion

    As noted in the introduction to the analysis of impacts section, 
FDA is certifying that the final rule will not have a significant 
impact on a substantial number of small entities. We provided the above 
information to explain the costs and benefits of the rule. There are 
currently over 400 manufacturers of medical gloves, a vast majority of 
which are foreign and not covered by the Regulatory Flexibility Act. 
There will be little to no impact on domestic entities. Moreover, FDA 
does not expect any increased manufacturer costs to be directly passed 
on to end users because the cost increases will affect only a minority 
of global manufacturers and, therefore, competition will likely force 
these manufacturers to absorb these costs.
    The estimated annualized costs equal $6.6 million using either a 3-
percent annual discount rate or a 7-percent annual discount rate. 
Benefits of avoiding transmissions of blood-borne pathogens and 
unnecessary blood screens have been estimated to equal $14.8 million 
(using a 3-percent discount rate) or $15.1 million (using a 7-percent 
discount rate). The final rule is estimated to result in average 
annualized net benefits of $8.2 million (using a 3-percent discount 
rate) or $8.5 million (using a 7-percent discount rate).''
    2. On page 75875, in the second column, section V of the document 
is corrected to read:

``V. References

    The following references have been placed on display in the 
Division of Dockets Management and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday. FDA has verified the 
Web site addresses, but is not responsible for subsequent changes to 
the Web site after this document publishes in the Federal Register.
    1. Centers for Disease Control and Prevention (CDC), ``HIV/AIDS 
Surveillance Report,'' (vol. 12, no. 2) (pp 5-6), https://
www.cdc.gov/hiv/topics/surveillance/resources/reports/pdf/
hasr1202.pdf, 2000.
    2. CDC, ``Fact Sheet: Surveillance of Health Care Workers With 
HIV/AIDS,'' https://www.cdc.gov/hiv/pubs/facts/hcwsurv.htm, 2001.
    3. Id.
    4. CDC, ``Fact Sheet: Viral Hepatitis B,'' https://www.cdc.gov/
ncidod/diseases/hepatitis/b/fact.htm, 2003.
    5. Id.
    6. Id.
    7. CDC, Morbidity and Morality Weekly Report, ``Updated U.S. 
Public Health Service Guidelines for the Management of Occupational 
Exposures to HBV, HCV, and HIV and Recommendations for Postexposure 
Prophylaxis,'' https://www.cdc.gov/mmwr/preview/mmwrhtml/
rr5011a1.htm, 2001.
    8. CDC, ``Fact Sheet: Viral Hepatitis C,'' https://www.cdc.gov/
ncidod/diseases/hepatitis/c/fact.htm, 2003.
    9. Id.
    10. U.S. International Trade Commission, Interactive Tariff and 
Trade Dataweb: Import Statistics, (Data file), available from http:/
/dataweb.usitc.gov/, 2004.
    11. Eastern Research Group, Inc., ``Cost Analysis of the 
Labeling and Related Testing Requirements for Medical Glove 
Manufacturers (Table 2),'' Lexington, MA: Eastern Research Group, 
Inc., March 2002.
    12. Bureau of Labor Statistics, ``Career Guide to Industries: 
Health Services,'' https://www.bls.gov/oco/cg/cgs035.htm, 2002-2003.
    13. Winchester Engineering & Analytical Center, Office of 
Regulatory Affairs Web Reports (data file), available from https://
webrpt.ora.fda.gov (follow ``Access Reports''), 2001.
    14. Id.
    15. Id.
    16. Id.
    17. Character, B. J., R. M. McLaughlin, C. S. Hedlund, et al., 
``Postoperative Integrity of Veterinary Surgical Gloves,'' Journal 
of the

[[Page 2444]]

American Animal Hospital Association, 39, pp. 311 to 320, May/June 
2003.
    18. Mudarri, D. H., ``The Costs and Benefits of Smoking 
Restrictions: An Assessment of the Smoke-Free Environment Act of 
1993,'' (H.R. 3434) (p. 14), Washington, DC, U.S. Environmental 
Protection Agency, April 1994.
    19. Mudarri, D. H., ``The Costs and Benefits of Smoking 
Restrictions: An Assessment of the Smoke-Free Environment Act of 
1993,'' (H.R. 3434) (Appendix A-1), Washington, DC, U.S. 
Environmental Protection Agency; Kaplan, R. M., J. W. Bush, & C. C. 
Berry, Health Status: Types of Validity and the Index of Well-Being, 
Health Services Research Journal, pp. 478-507, winter 1976.
    20. Kaplan, R. M., J. W. Bush, C. C. Berry, (1976, Winter), 
``Health Status: Types of Validity and the Index of Well-Being,'' 
Health Services Research Journal, pp. 478-507; M. M. Chen, J. W. 
Bush, D. L. Patrick, (1975), ``Social Indicators for Health Planning 
and Policy Analysis,'' Policy Sciences Journal, 6, pp. 71-89; R. M. 
Kaplan, J. W. Bush, (1982), ``Health Related Quality of Life 
Measurement for Evaluation Research and Policy Analysis,'' Health 
Psychology, 1(1), pp. 61-80.
    21. R. M. Kaplan, J. W. Bush, C. C. Berry, ``Health Status: 
Types of Validity and the Index of Well-Being,'' Health Services 
Research Journal, pp. 478-507, winter 1976.
    22. Tufts--New England Medical Center. The CEA Registry: Catalog 
of Preference Scores, https://www.tufts-nemc.org/cearegistry/data/
phaseIIpreferenceweights.pdf, April 5, 2006.
    23. U.S. Census Bureau, Statistical Abstract of the United 
States: 2002, https://www.census.gov/prod/2003pubs/02statab/
vitstat.pdf, 2002, December.
    24. Tufts--New England Medical Center, The CEA Registry: Catalog 
of Preference Scores, https://www.tufts-nemc.org/cearegistry/data/
phaseIIpreferenceweights.pdf, April 5, 2006.
    25. Id.
    26. M. G. Marin, J. Van Lieu, A. Yee, et al., ``Cost-
Effectiveness of a Post-Exposure HIV Chemoprophylaxis Program for 
Blood Exposures in Health Care Workers,'' Journal of Occupational 
and Environmental Medicine, 41(9), pp. 754-760, September 1999.
    27. ``Time to Top Off Your Tank?: The Red Cross Says Blood 
Safety Costs Are Pumping Up Prices,'' The Washington Post, p. T07, 
June 12, 2001.
    28. Lerman, C., Schwartz, & Schwartz, Marc, ``Adherence and 
Psychological Adjustment Among Women at High Risk for Breast 
Cancer,'' Breast Cancer Research and Treatment, 28, pp. 145-155, 
1993.
    29. Shrout, P. E., ``Scaling of Stressful Life Events,'' (in) 
Dohrenwend, B. Snell, B. P. Dohrenwend (Eds.), Stressful Life Events 
& Their Contexts (pp. 29-47), New Brunswick, NJ, Rutgers University 
Press, 1984.
    30. Kaplan, R. M., J. W. Bush, C. C. Berry, `` Health Status: 
Types of Validity and the Index of Well-Being,'' Health Services 
Research Journal, pp. 478-507, winter 1976.
    31. E. Alderete, T. C. Juarbe, C. P. Kaplan, et al., 
``Depressive Symptoms Among Women With an Abnormal Mammogram,'' 
Psycho-Oncology, 15, pp. 66-78, 2006.''

    Dated: January 11, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-682 Filed 1-18-07; 8:45 am]
BILLING CODE 4160-01-S