Federal Register / Vol. 77, No. 28 / Friday, February 10, 2012 / Proposed Rules 7109 

ADDRESSES: You may submit comments, 

identified by RIN 1250–AA02, by any of 

the following methods: 

• Federal eRulemaking Portal: 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: (202) 693–1304 (for comments 

of six pages or less). 

• Mail: Debra A. Carr, Director, 

Division of Policy, Planning, and 

Program Development, Office of Federal 

Contract Compliance Programs, Room 

C–3325, 200 Constitution Avenue NW., 

Washington, DC 20210. 

FOR FURTHER INFORMATION CONTACT: 

Debra A. Carr, Director, Division of 

Policy, Planning and Program 

Development, Office of Federal Contract 

Compliance Programs, 200 Constitution 

Avenue NW., Room C–3325, 

Washington, DC 20210. Telephone: 

(202) 693–0103 (voice) or (202) 693– 

1337 (TTY). 

SUPPLEMENTARY INFORMATION: On 

December 9, 2011, OFCCP published a 

proposed rule entitled, ‘‘Affirmative 

Action and Nondiscrimination 

Obligations of Contractors and 

Subcontractors Regarding Individuals 

with Disabilities’’ (76 FR 77056). OFCCP 

was to receive comments on this NPRM 

on or before February 7, 2012. 

Various organizations and entities 

submitted requests to extend the 

comment period by an additional 90 

days or more. We considered these 

requests and determined that it is 

appropriate to provide an additional 14- 

day period for comment on the 

proposed regulation. We are, therefore, 

extending the comment period until, 

Tuesday, February 21, 2012. 

Extension of Comment Period: OFCCP 

determined that the public could use 

additional time to review the potential 

impact of the proposed requirements. 

Therefore, to allow the public sufficient 

time to review and comment on the 

NPRM, OFCCP is extending the 

comment period until February 21, 

2012. 

Signed at Washington, DC, this 6th day of 

February, 2012. 

Patricia A. Shiu, 

Director, Office of Federal Contract 

Compliance Programs. 

[FR Doc. 2012–3106 Filed 2–7–12; 11:15 am] 

BILLING CODE 4510–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 71 

[Docket No. CDC–2012–0002] 

RIN 0920–AA47 

Establishment of User Fees for 

Filovirus Testing of Nonhuman Primate 

Liver Samples 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice of Proposed Rulemaking 

and request for comments. 

SUMMARY: Through this Notice of 

Proposed Rulemaking (NPRM), the 

Centers for Disease Control and 

Prevention (CDC), located within the 

Department of Health and Human 

Services (HHS) is proposing to establish 

a user fee for filovirus testing of all 

nonhuman primates that die during the 

HHS/CDC-required 31-day quarantine 

period for any reason other than trauma. 

We propose to establish a filovirus 

testing service at HHS/CDC because 

testing is no longer being offered by the 

only private, commercial laboratory that 

previously performed these tests. This 

testing service will be funded through 

user fees. Elsewhere in this issue of the 

Federal Register, HHS/CDC is 

simultaneously publishing a companion 

direct final rule that proposes identical 

filovirus testing and user fee 

requirements in this Federal Register 

because it believes that these 

requirements are non-controversial and 

unlikely to generate significant adverse 

comment. If HHS/CDC does not receive 

any significant adverse comment on the 

direct final rule within the specified 

comment period, it will publish a notice 

in the Federal Register withdrawing 

this notice of proposed rulemaking and 

confirming the effective date of the 

direct final rule within 30 days after the 

end of the comment period on the direct 

final rule. If HHS/CDC receives any 

timely significant adverse comment, it 

will withdraw the direct final rule in 

part or in whole by publication of a 

notice in the Federal Register within 30 

days after the comment period ends and 

proceed with notice and comment 

under this notice of proposed 

rulemaking. A significant adverse 

comment is one that explains: Why the 

direct final rule is inappropriate, 

including challenges to the rule’s 

underlying premise or approach; or why 

the direct final rule will be ineffective 

or unacceptable without a change. 

DATES: Submit written or electronic 

comments by April 10, 2012. 

ADDRESSES: You may submit comments, 

identified by ‘‘RIN 0920–AA47’’: By any 

of the following methods: 

• Internet: Access the Federal erulemaking portal at http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Division of Global Migration 

and Quarantine, Centers for Disease 

Control and Prevention, 1600 Clifton 

Road NE., MS–03, Atlanta, Georgia 

30333, ATTN: NHP NPRM. 

Instructions: All submissions received 

must include the agency name and 

docket number or Regulation Identifier 

Number (RIN) for this rulemaking. All 

comments will be posted without 

change to http://regulations.gov, 

including any personal information 

provided. For detailed instructions on 

submitting comments and additional 

information on the rulemaking process, 

see the ‘‘Public Participation’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, please go to 

http://www.regulations.gov. Comments 

will be available for public inspection 

Monday through Friday, except for legal 

holidays, from 9 a.m. until 5 p.m., 

Eastern Time, at 1600 Clifton Road NE., 

Atlanta, Georgia 30333. Please call 

ahead to 1–866–694–4867 and ask for a 

representative in the Division of Global 

Migration and Quarantine (DGMQ) to 

schedule your visit. To download an 

electronic version of the rule, access 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: For 

questions concerning this notice of 

proposed rulemaking: Ashley A. 

Marrone, JD, Centers for Disease Control 

and Prevention, 1600 Clifton Road NE., 

Mailstop E–03, Atlanta, Georgia 30333; 

telephone 404 498–1600. For 

information concerning program 

operations: Dr. Robert Mullan, Centers 

for Disease Control and Prevention, 

1600 Clifton Road NE., Mailstop E–03, 

Atlanta, Georgia 30333; telephone 404 

498–1600. 

SUPPLEMENTARY INFORMATION: This 

preamble is organized as follows: 

I. Public Participation 

II. Background 

III. Rationale for Proposal 

IV. User Fee 

V. Services and Activities Covered by This 

User Fees 

VI. Analysis of User Fee Charge (Cost to 

Government) 

VII. Payment Instructions 

VIII. Regulatory Analysis 

IX. References 

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7110 Federal Register / Vol. 77, No. 28 / Friday, February 10, 2012 / Proposed Rules 

I. Public Participation 

Interested persons are invited to 

participate in this rulemaking by 

submitting written views, opinions, 

recommendations, and data. Comments 

received, including attachments and 

other supporting materials, are part of 

the public record and subject to public 

disclosure. Do not include any 

information in your comment or 

supporting materials that you do not 

wish to be disclosed publicly. 

Comments are invited on any topic 

directly related to this proposed rule. 

II. Background 

Filoviruses belong to a family of 

viruses known to cause severe 

hemorrhagic fever in humans and 

nonhuman primates (NHPs). So far, only 

two members of this virus family have 

been identified: Ebola virus and 

Marburg virus. Five species of Ebola 

virus have been acknowledged: Zaire, 

Sudan, Reston, Ivory Coast, and 

Bundibugyo. Most strains of Ebola virus 

can be highly fatal in humans, and 

while the Reston strain is the only strain 

of filovirus that has not been reported to 

cause disease in humans, it can be fatal 

in monkeys. (http://www.cdc.gov/ 

ncidod/dvrd/spb/mnpages/dispages/ 

filoviruses.htm). 

Ebola hemorrhagic fever was first 

recognized in 1976, when two 

epidemics occurred in southern Sudan 

and in Zaire. Since that time, multiple 

outbreaks have occurred, mostly in 

Central Africa, and all have been 

associated with high (45–90%) casefatality rates in humans (for an updated 

list see http://www.cdc.gov/ncidod/ 

dvrd/spb/mnpages/dispages/ebola/ 

ebolatable.htm). In these epidemics, 

transmission of the disease originated or 

occurred in a hospital (often by 

contaminated needles) and was 

followed by person-to-person 

transmission by individuals who were 

exposed to, or had close contact with 

blood or secretions from seriously ill 

patients. 

The ecology, natural history, and 

mode of transmission of Ebola virus in 

nature, and of the related Marburg virus, 

are becoming more clearly understood 

with the implication of bats as 

reservoirs. The incubation period for 

Ebola disease is 5–9 days (range: 2–15 

days) but can be shorter with parenteral 

transmission. Disease onset is abrupt 

and characterized by severe malaise, 

headache, high fever, myalgia, joint 

pains, and sore throat. The progression 

is rapid and includes pharyngitis, 

conjunctivitis, diarrhea, abdominal 

pain, and occasionally facial edema and 

jaundice. Severe thrombocytopenia can 

occur, with hemorrhagic manifestations 

ranging from petechiae to frank 

bleeding. Death occurs primarily as a 

result of multi-organ failures. There is 

no specific therapy, and patient 

management is usually limited to 

supportive measures. The disease in 

nonhuman primates is very similar to 

that in humans, with a very high 

mortality. 

On January 19, 1990, in response to 

the identification of Ebola-Reston virus 

in NHPs imported from the Philippines, 

HHS/CDC published interim guidelines 

for handling NHPs during transit and 

also during quarantine (1). Importers of 

NHPs were informed by letter from the 

HHS/CDC Director on March 15, 1990, 

that they must comply with specific 

isolation and quarantine standards 

under 42 CFR part 71 for continued 

registration as an importer of NHPs (2). 

On March 23, 1990, HHS/CDC held a 

meeting at CDC headquarters in Atlanta, 

Georgia, at which the public could 

comment on new guidelines for the 

importation of NHPs and the potential 

impact of a temporary ban on the 

importation of cynomolgus monkeys 

into the United States (3). After 

considering information received at this 

public meeting, coupled with an April 

4, 1990 confirmation of asymptomatic 

Ebola virus infection in four NHP 

caretakers and serologic findings 

suggesting that cynomolgus, African 

green, and rhesus monkeys posed a risk 

for human filovirus infection, HHS/CDC 

concluded that these three species were 

capable of being an animal host or 

vector of human disease (4). 

As a result, on April 20, 1990, HHS/ 

CDC published a notice in the Federal 

Register requiring a special-permit for 

importing cynomolgus, African green, 

and rhesus monkeys (5). To be granted 

a special-permit, importers must submit 

a plan to HHS/CDC describing specific 

isolation, quarantine, and 

communicable disease control 

measures. The plan must detail the 

measures to be carried out at every step 

of the chain of custody, from 

embarkation at the country of origin, 

through delivery of the NHPs to the 

quarantine facility and the completion 

of the required quarantine period. 

Additional requirements include 

detailed testing procedures for all 

quarantined NHPs to rule out the 

possibility of filovirus infection. When 

importers demonstrate compliance with 

these special-permit requirements, 

HHS/CDC authorizes continued 

shipments under the same permit for a 

period of 180 days. Certain components 

of the special-permit requirement have 

changed slightly in response to 

surveillance findings and the 

development of improved laboratory 

tests. As indicated in the 1990 notice, 

importers were informed of these 

changes by letter from HHS/CDC (6). 

The current special-permit notice 

requires filovirus antigen-detection 

testing on liver specimens from any 

NHP that dies during quarantine for 

reasons other than trauma (7, 8). 

Antibody testing is also required on 

surviving NHPs that exhibit signs of 

possible filovirus infection before the 

cohort is released from quarantine (9). 

Since October 10, 1975, HHS/CDC has 

prohibited the importation of NHPs 

except for scientific, educational, or 

exhibition purposes. Over time, various 

measures (e.g., reports, letters, 

guidelines, notices), have been used to 

support implementation of these 

regulations. On January 5, 2011, HHS/ 

CDC posted a Notice of Proposed 

Rulemaking (NPRM) to begin the 

process of revising these requirements. 

The NPRM was intended to solicit 

public comment and feedback on the 

issue of NHP importation to determine 

the need for further rulemaking. Please 

see the docket details for HHS–OS– 

2011–0002 on www.Regulations.gov, for 

more information. The public comment 

period ended on April 25, 2011. HHS/ 

CDC is now working toward finalizing 

the proposed rule and is not seeking 

additional comment on the NPRM 

through this rulemaking. 

Laboratory testing of suspected NHPs 

and early detection of infected animals 

within the quarantine period prevents 

spread of disease among NHPs and 

caretakers (4). Since the implementation 

and strengthening of the 1990 specialpermit requirements for importing 

nonhuman primates into the United 

States, the morbidity and mortality of 

imported animals has decreased from an 

estimated 20% to less than 1% (10). 

Since 1990, these laboratory tests have 

been conducted by a sole commercial 

laboratory. Recently, a number of 

circumstances have arisen such that this 

laboratory is no longer able to perform 

the testing for filovirus required on liver 

specimens from monkeys that die 

during the HHS/CDC-mandated 

quarantine. Further, HHS/CDC notes 

that the reagents required for this testing 

are not commercially available and 

production of the reagents requires a 

biosafety level 4 laboratory (BSL–4). A 

BSL–4 laboratory is also required during 

part of the testing procedure. To our 

knowledge, neither commercial entities 

nor Federal laboratories other than those 

at HHS/CDC are planning to offer this 

service. Because HHS/CDC has the 

required laboratory facility, access to the 

reagents, and experienced personnel, it 

has started performing this testing when 

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Federal Register / Vol. 77, No. 28 / Friday, February 10, 2012 / Proposed Rules 7111 

required and in the absence of a viable 

alternative. 

III. Rationale for Proposal 

Through this NPRM, HHS/CDC is 

proposing to establish a user fee to 

reimburse HHS/CDC for the costs 

incurred performing the required 

filovirus testing and seeks public 

comment on this proposal. If 

promulgated as proposed, upon the 

effective date of the final rule, every 

NHP quarantine facility will be 

contacted by HHS/CDC’s Division of 

Global Migration and Quarantine 

(DGMQ), and will be instructed how to 

transfer tissue specimens to HHS/CDC 

for testing. After receipt of the 

specimens, HHS/CDC will process the 

specimens in its BSL–4 laboratory and 

test the specimens by an antigendetection enzyme-linked 

immunosorbant assay (ELISA) or other 

appropriate methodology. Each 

specimen will be held for six months. 

After six months, the specimen will be 

disposed of following established HHS/ 

CDC protocol. Based on information 

supplied by the commercial laboratory, 

HHS/CDC estimates that between 100 

and 150 specimens per year are 

expected to be received and tested. 

Results will be provided to the NHP 

importers. If a positive test result is 

found, HHS/CDC will ensure that the 

NHP cohort is not released from HHS/ 

CDC required quarantine until the 

health status of the full cohort is 

determined. This testing protocol would 

be maintained until further notice. 

HHS/CDC has chosen to establish this 

testing service based on the 

unanticipated loss of the only 

commercially available antigendetection ELISA filovirus testing 

facility. Currently, there are no 

commercially available assays for 

filovirus antigen detection in tissue 

samples and this testing cannot readily 

be performed in the private sector 

because the testing requires a BSL–4 

laboratory and the reagents are not 

commercially available. Other factors 

which contribute to the necessity of the 

testing service include the limited 

availability of BSL–4 laboratories, the 

special expertise required to perform 

these tests, the lack of commerciallyavailable reagents, the need and 

requirement for continued and ongoing 

filovirus testing to protect public health, 

the negative effect on science, education 

and exhibition if imports of NHPs are 

disrupted, and the lack of other testing 

alternatives. 

Nothing in this proposal is intended 

to prohibit a private sector facility from 

developing the capability and offering 

this same service in the future. The 

testing of non-human primate samples 

is necessary to prevent and control a 

potential outbreak of a filovirus 

infection in imported monkeys and to 

prevent the potential spread of 

filoviruses to humans. 

IV. User Fees 

Title V of the Independent Offices 

Appropriation Act of 1952 (31 U.S.C. 

9701) (‘‘IOAA’’) provides general 

authority to Federal agencies to 

establish user fees through regulations. 

The IOAA sets parameters for any fee 

charged under its authority. Each charge 

shall be: 

(1) Fair; and 

(2) Based on— 

(A) The costs to the Government; 

(B) The value of the service or thing 

to the recipient; 

(C) Public-policy or interest served; 

and 

(D) Other relevant facts. 

OMB Circular A–25 (‘‘the Circular’’) 

establishes general policy for 

implementing user fees, including 

criteria for determining amounts and 

exceptions, and guidelines for 

implementation. According to the 

Circular, its provisions must be applied 

to any fees collected pursuant to the 

IOAA authority. 

The Circular states that ‘‘[a] user 

charge * * * will be assessed against 

each identifiable recipient for special 

benefits derived from Federal activities 

beyond those received by the general 

public.’’ The Circular gives three 

examples of when the special benefit is 

considered to accrue, including when a 

Government service: (a) Enables the 

beneficiary to obtain more immediate or 

substantial gains or values (which may 

or may not be measurable in monetary 

terms) than those that accrue to the 

general public (e.g., receiving a patent, 

insurance, or guarantee provision, or a 

license to carry on a specific activity or 

business or various kinds of public land 

use); or (b) provides business stability or 

contributes to public confidence in the 

business activity of the beneficiary (e.g., 

insuring deposits in commercial banks); 

or (c) is performed at the request of or 

for the convenience of the recipient, and 

is beyond the services regularly received 

by other members of the same industry 

or group or by the general public (e.g., 

receiving a passport, visa, airman’s 

certificate, or a Customs inspection after 

regular duty hours). 

The Circular sets forth guidelines for 

determining the amount of user charges 

to assess. When the Government is 

acting in its sovereign capacity, user 

charges should be sufficient to cover the 

full cost to the Federal Government of 

providing the service, resource, or good. 

The Circular sets forth criteria for 

determining full cost. ‘‘Full cost 

includes all direct and indirect costs to 

any part of the Federal Government of 

providing a good, resource, or service.’’ 

Examples of these types of costs 

include, but are not limited to, direct 

and indirect personnel costs, including 

salaries and fringe benefits; physical 

overhead, consulting, and other indirect 

costs, including material and supply 

costs, utilities, insurance, travel, and 

rents; management and supervisory 

costs; and the costs of enforcement, 

collection, research, establishment of 

standards, and regulation. Full costs are 

determined based on the best available 

records of the agency. 

Agencies are responsible for the 

initiation and adoption of user charge 

schedules consistent with the guidance 

listed in the Circular. In doing so, 

agencies should identify the services 

and activities covered by the Circular; 

determine the extent of the special 

benefits provided; and apply the 

principles set forth in the Circular in 

determining full cost or market cost as 

appropriate. 

Finally, CDC has legal authority to 

retain collected user fees through its 

annual appropriations bill. In fiscal year 

2012, this authority is provided through 

the Consolidated Appropriations Act of 

2012, Public Law 112–74, 125 Stat. 

1069, 1070 (2011). 

V. Services and Activities Covered by 

This User Fee 

HHS/CDC is establishing a user fee to 

recoup the costs associated with 

performing the required testing. The 

user fee will cover the costs of the test 

for filovirus for specimens submitted to 

HHS/CDC. The following is a list of 

services and activities that are covered 

by the user fee: 

• Providing information to the 

participants about the service, including 

instructions on submission of samples 

and payment; 

• Receiving payment and maintaining 

account, including distributing funds; 

• Tracking the shipment to ensure a 

safe arrival at HHS/CDC; 

• Providing reagents for and 

performing the antigen-detection test on 

submitted NHP liver samples in a BSL– 

4, high-containment facility; 

• Performing all provided services in 

accordance with industry standards, 

including quality assurance, handling 

and processing procedures, and 

hazardous medical waste guidelines; 

and 

• Ensuring that the importer receives 

the test results in a timely manner. 

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7112 Federal Register / Vol. 77, No. 28 / Friday, February 10, 2012 / Proposed Rules 

VI. Analysis of User Fee Charge (Cost 

to the Government) 

HHS/CDC’s analysis of costs to the 

Government is based on the current 

methodology (ELISA) used to test NHP 

liver samples. This cost determines the 

amount of the user fee. HHS/CDC notes 

that the use of a different methodology 

or changes in the availability of ELISA 

reagents will affect the amount of the 

user fee. HHS/CDC will impose the fee 

by schedule and will notify importers of 

changes to the user fee by notice in the 

Federal Register. Importers may also 

contact HHS/CDC at 404–498–1600 or 

check its Web site (http://www.cdc.gov/ 

animalimportation/) for an up-to-date 

fee schedule. 

In its analysis of cost, HHS/CDC 

considered five components: (1) The 

cost of reagents and materials; (2) the 

cost of the BSL–4 laboratory in reagent 

production and during the assay; (3) the 

cost of irradiation of the sample; (4) 

personnel costs to perform the testing; 

and (5) administrative costs. The total 

cost to the Government is summarized 

in Table 1 followed by a description of 

each component; all monies reflected 

are in U.S. Dollars (USD). 

TABLE 1—SUMMARY CALCULATIONS

OF USER FEE CHARGE-PER-TEST

Components Costs 

(USD) 

1. Use of reagents and other materials ................................................ $100 

2. Use of BSL–4 lab facility .............. 112 

3. Irradiation (inactivation) of sample 150 

4. Personnel costs to conduct testing ................................................. 145 

5. Administrative costs ..................... 33 

ESTIMATED TOTAL ................. 540 

User Fee .................................... 540 

The first component in the estimate is 

the cost of the reagent materials and 

other materials necessary to perform the 

test. Two reagents are used to prepare 

the specific antibodies needed in the 

test. These reagents are not 

commercially available and must be 

made in-house by HHS/CDC scientists. 

Since these reagents are not 

commercially available, there is no 

commercial or observable product 

pricing. HHS/CDC estimates the cost for 

these reagents to be $70.00. This amount 

includes the cost of production and 

validation of the reagents. Material costs 

include plastic plates, pipettes, and 

other reagents. These items are available 

commercially and their cost is estimated 

at $30.00. Thus, the total estimated cost 

for this component totals $100.00 per 

test. This cost can be a bit higher or 

lower depending on how many tests are 

run at the same time. If the test requests 

come in one at a time, then the cost 

might be above $100, if there is more 

than one request at a time, the cost 

might be a bit less than $100. The test 

calls for the same amount of reagents for 

one or 3 samples to test. 

The second component is the cost of 

the BSL–4 facility that is used to 

develop the reagents. We have estimated 

this cost on the charges made by 

University of Texas Medical Branch at 

Galveston (UTMB) of $28 per hour. The 

UTMB is the only BSL–4 facility in the 

United States that has developed 

commercial fees for the use of their labs. 

In the ELISA methodology, scientists 

need four hours in the BSL–4 laboratory 

to process the sample. The cost of this 

component is $112.00. 

The third component in the cost 

estimate is the cost to inactivate the 

sample by irradiation in an irradiator. 

For this component, we estimate the 

cost to use an irradiator at $30 per hour. 

This estimate is based on a five-year 

cost of $300,000 to HHS/CDC to run and 

maintain the irradiator. Irradiators are 

extremely expensive to maintain for a 

number of reasons. Only research 

facilities have irradiator equipment 

because of the need to inactivate highhazard pathogens. Safety restrictions on 

irradiators are complex and time 

consuming; requiring frequent, 

professional safety inspections and 

complex annual training for all 

personnel that work with or near the 

irradiator. Finally, a high level of 

security must be maintained because the 

complexities of using irradiators and the 

specimens being irradiated require 

access to be controlled and monitored. 

Typically it takes five hours to 

inactivate a sample, at a total estimated 

irradiation cost of $150. 

The fourth component of the cost is 

the hourly wage and benefits of 

personnel who perform the laboratory 

tests. We assume that the scientist 

performing the test is a microbiologist 

with a masters’ degree. Most of the 

personnel in this category are paid at a 

GS 11 level. For the purposes of this 

estimate, we have assumed a pay level 

of GS 11, Step 3. We set the basic wage 

at $25.70 per hour, and a benefit of 30% 

for a total hourly salary of $33.41 an 

hour (U.S. Office of Personnel 

Management 2010 General Schedule 

(GS) Locality Pay Tables for Atlanta; 

http://www.opm.gov/oca/11tables/ 

indexgs.asp). In total, the tests take 

about 13 hours (four hours in the BSL– 

4; three hours of irradiation; and six 

hours running the test with 

interpretation). However, we assume 

that the person working on this test will 

be carrying on other duties 

simultaneously. Therefore, we assign 

one-third of the 13 hours of work time 

to the fourth part, or $145.00 ($434.33/ 

3). 

The fifth and final component is the 

administrative costs related to test result 

collection and dissemination. The 

individual responsible for the activities 

under this component is typically in a 

supervisory position. The supervisor 

examines the assay to ensure that the 

positive and negative tests (quality 

controls) are accurate, and to ensure that 

the test was performed according to 

prescribed scientific standards. The 

supervisor puts the results on a 

response form and sends the results to 

the importer with a copy to CDC’s 

Division of Global Migration and 

Quarantine (DGMQ). To calculate this 

cost, we used half an hour of the salary 

and benefits of a GS 14 level, Senior 

Health Scientist (601 series). The hourly 

rate of a GS14, level 3 is $50 (U.S. Office 

of Personnel Management 2010 General 

Schedule (GS) Locality Pay Tables for 

Atlanta; http://www.opm.gov/oca/ 

10tables/indexgs.asp). We added 30% of 

the hourly rate for benefits to total 

$65.00. Thirty minutes of this 

individual’s time is $33.00. 

Total cost: Adding these parts (Table 

1) results in a grand total of $540. We 

note that our results can potentially vary 

from this figure for a couple of reasons. 

First, as mentioned already, commercial 

data are not available for some of the 

reagents so our calculation of their costs 

is an estimate and not based on 

observed market pricing. Second, the 

costs will vary depending on how many 

tests are conducted at one time. If 

multiple tests are run concurrently, then 

the costs would be a bit less. If only one 

test is conducted at one time, the costs 

will be relatively higher. Therefore, we 

set the cost of reimbursement per test at 

$540. We feel confident that this is a fair 

price to the importers because this 

amount is consistent with the sum 

charged by the commercial lab of 

$500.00 that previously performed these 

tests. We also note that our assumption 

of the effect of multiple tests is 

supported by past experience. HHS/CDC 

receives notification of about 100 to 150 

requests performed per year. Although 

HHS/CDC cannot control the flow of 

tests and cannot forecast how many 

tests will be underway at any given 

point in time, HHS/CDC estimates that 

the total amount of fees charged will 

range from about $50,000 to $75,000 per 

year. The user fee charged for the testing 

will cover the costs of the test. 

HHS/CDC will impose the user fee by 

schedule. An up-to-date fee schedule is 

available from the Division of Global 

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Federal Register / Vol. 77, No. 28 / Friday, February 10, 2012 / Proposed Rules 7113 

Migration & Quarantine, Centers for 

Disease Control and Prevention, 1600 

Clifton Road, Atlanta, Georgia 30333, 

404–498–1600, or [insert url of Web 

site]. 

VII. Payment Instructions 

HHS/CDC Importers should submit a 

check or money order in the amount of 

$540.00 (USD) made payable to Centers 

for Disease Control and Prevention for 

each test conducted at the time that 

specimens are submitted to the CDC for 

testing. The check(s) should be sent to 

Centers for Disease Control and 

Prevention, P.O. Box 15580, Atlanta, GA 

30333. 

VIII. Regulatory Analyses 

A. Required Regulatory Analyses Under 

Executive Orders 12866 and 13563 

We have examined the impacts of the 

proposed rule under Executive Orders 

12866 and 13563, which direct agencies 

to assess all costs and benefits of 

available regulatory alternatives and, 

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). 

Because the purpose of this rule is to 

provide a framework to determine a fair 

fee to charge for a service that has 

become unavailable in private, 

commercial markets within the United 

States, we have determined that the rule 

will not violate the intent of either of 

the Executive Orders because it will in 

no way prevent a private entity from 

entering the field and providing a 

similar, privatized service. If any private 

entity expresses an interest in providing 

this service, we will strongly encourage 

them to do so. 

B. Regulatory Flexibility Act 

We have examined the impacts of the 

proposed rule under the Regulatory 

Flexibility Act (5 U.S.C. 601–612). 

Unless we certify that the rule is not 

expected to have a significant economic 

impact on a substantial number of small 

entities, the Regulatory Flexibility Act, 

as amended by the Small Business 

Regulatory Enforcement Fairness Act 

(SBREFA), requires agencies to analyze 

regulatory options that would minimize 

any significant economic impact of a 

rule on small entities. We certify that 

this rule will not have a significant 

economic impact on a substantial 

number of small entities within the 

meaning of the RFA. 

C. Small Business Regulatory 

Enforcement Fairness Act of 1996 

This regulatory action is not a major 

rule as defined by Sec. 804 of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996. This proposed rule 

will not result in an annual effect on the 

economy of $100,000,000 or more; a 

major increase in cost or prices; or 

significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or on the 

ability of United States-based 

companies to compete with foreignbased companies in domestic and 

export markets. 

D. The Paperwork Reduction Act of 

1995 

HHS/CDC has reviewed the 

information collection requirements of 

the proposed rule and has determined 

that the information collection 

requested in the proposed rule is 

already approved by the Office of 

Management and Budget (OMB) under 

OMB Control No. 0920–0263, expiration 

date 6/30/2014. The proposed rule does 

not contain any new data collection or 

record keeping requirements. 

E. National Environmental Policy Act 

(NEPA) 

Pursuant to 48 FR 9374 (list of HHS/ 

CDC program actions that are 

categorically excluded from the NEPA 

environmental review process), HHS/ 

CDC has determined that this action 

does not qualify for a categorical 

exclusion. In the absence of an 

applicable categorical exclusion, the 

Director, CDC, has determined that 

provisions amending 42 CFR 71.53 will 

not have a significant impact on the 

human environment. Therefore, neither 

an environmental assessment nor an 

environmental impact statement is 

required. 

F. Civil Justice Reform (Executive Order 

12988) 

This proposed rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. Under this proposed 

rule: (1) All State and local laws and 

regulations that are inconsistent with 

this rule will be preempted; (2) no 

retroactive effect will be given to this 

rule; and (3) administrative proceedings 

will not be required before parties may 

file suit in court challenging this rule. 

G. Executive Order 13132 (Federalism) 

The Department has reviewed this 

rule in accordance with Executive Order 

13132 regarding federalism, and has 

determined that it does not have 

‘‘federalism implications.’’ The rule 

does not ‘‘have substantial direct effects 

on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government.’’ 

H. Plain Language Act of 2010 

Under Public Law 111–274 (October 

13, 2010), executive Departments and 

Agencies are required to use plain 

language in documents that explain to 

the public how to comply with a 

requirement the Federal Government 

administers or enforces. HHS has 

attempted to use plain language in 

promulgating this rule consistent with 

the Federal Plain Writing Act 

guidelines. 

I. Conclusion 

In accordance with the provisions of 

Executive Order 12866, this proposed 

rule was not reviewed by the Office of 

Management and Budget. 

IX. References 

1. Centers for Disease Control and 

Prevention. Update: Ebola-Related 

Filovirus Infection in Nonhuman 

Primates and Interim Guidelines for 

Handling Nonhuman Primates during 

Transit and Quarantine. Morbidity and 

Mortality Weekly Report MMWR 1990; 

39(2):22–24, 29–30. 

2. Roper, W.L. Dear interested party (letter). 

March 15, 1990. Available upon request: 

(404) 639–1600. 

3. 55 FR 10288, March 20, 1990, 

‘‘Importation of Nonhuman Primates: 

Meeting.’’ 

4. Centers for Disease Control and 

Prevention. Update: Filovirus Infection 

in Animal Handlers. Morbidity and 

Mortality Weekly Report MMWR 1990; 

39(13):221. 

5. 55 FR 15210, April 20, 1990, Requirement 

for a Special-permit to Import 

Cynomolgus, African Green, or rhesus 

Monkeys into the United States. 

6. Roper, W.L. Dear interested party (letter). 

October 10, 1991. Available upon 

request: (404) 639–1600. 

7. Ksiazek, Thomas G.; Rollin, Pierre E.; 

Jahrling, Peter B.; Johnson, Eugene; 

Dalgard, Dan W., and Peters, Clarence J. 

Enzyme immunosorbent assay for Ebola 

virus antigens in tissues of infected 

primates. Journal of Clinical 

Microbiology. 1992; (304):947–950. 

8. Ksiazek, Thomas G. Laboratory diagnosis 

of filovirus infections in nonhuman 

primates. Laboratory Animal. 1991; 

20(7):34–46. 

9. Tipple, M.A. Dear interested party (letter). 

March 5, 1996. Available upon request: 

(404) 639–1600. 

10. Demarcus, T., Tipple, M., Ostrowski, S., 

U.S. Policy for Disease Control among 

Imported Nonhuman Primates, J Infect 

Dis. (1999) 179 (supplement 1): S281– 

S282. 

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7114 Federal Register / Vol. 77, No. 28 / Friday, February 10, 2012 / Proposed Rules 

List of Subjects in 42 CFR Part 71 

Communicable diseases, Public 

health, Quarantine, Reporting and 

recordkeeping requirements, Testing, 

User fees. 

For the reasons set forth in the 

preamble, HHS proposes to amend 42 

CFR part 71 as follows: 

PART 71—FOREIGN QUARANTINE 

1. The authority citation for part 71 

continues to read as follows: 

Authority: Secs. 215 and 311 of the Public 

Health Service (PHS) Act, as amended (42 

U.S.C. 216, 243); section 361–369, PHS Act, 

as amended (42 U.S.C. 264–272); 31 U.S.C. 

9701. 

Subpart F—Importations 

2. In § 71.53, add paragraph (j) to read 

as follows: 

§ 71.53 Nonhuman primates. 

* * * * * 

(j) Filovirus Testing Fee. (1) Nonhuman primate importers shall be 

charged a fee for filovirus testing of nonhuman primate liver samples submitted 

to the Centers for Disease Control and 

Prevention (CDC). 

(2) The fee shall be based on the cost 

of reagents and other materials 

necessary to perform the testing; the use 

of the laboratory testing facility; 

irradiation for inactivation of the 

sample; personnel costs associated with 

performance of the laboratory tests; and 

administrative costs for test planning, 

review of assay results, and 

dissemination of test results. 

(3) An up-to-date fee schedule is 

available from the Division of Global 

Migration & Quarantine, Centers for 

Disease Control and Prevention, 1600 

Clifton Road, Atlanta, Georgia 30333. 

Any changes in the fee schedule will be 

published in the Federal Register. 

(4) The fee must be paid in U.S. 

dollars at the time that the importer 

submits the specimens to HHS/CDC for 

testing. 

Dated: January 19, 2012. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2012–2841 Filed 2–9–12; 8:45 am] 

BILLING CODE 4163–18–P 

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