Establishment of User Fees for Filovirus Testing of Nonhuman Primate Liver Samples, 6971-6976 [2012-2843]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 77, Number 28 (Friday, February 10, 2012)]
[Rules and Regulations]
[Pages 6971-6976]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-2843]



[[Page 6971]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 71

[Docket No. CDC-2012-0003]
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: Direct final rule and request for comments.

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SUMMARY: Through this Direct Final Rule, the Centers for Disease 
Control and Prevention (CDC), located within the Department of Health 
and Human Services (HHS) is establishing a user fee for filovirus 
testing of all nonhuman primates that die during HHS/CDC-required 31-
day quarantine period for any reason other than trauma. We are amending 
regulations 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. The direct final rule does not impose 
any new burdens on the regulated community because the testing of non-
human primates for filovirus is a long-standing requirement and the 
amount of the user fee is consistent with the amount previously charged 
commercially. HHS/CDC is therefore publishing a direct final rule 
because it does not expect to receive any significant adverse comment 
and believes that the establishment of an HHS/CDC testing program and 
imposition of user fees are non-controversial. However, in this Federal 
Register, HHS/CDC is simultaneously publishing a companion notice of 
proposed rulemaking that proposes identical filovirus testing and user 
fee requirements. If HHS/CDC does not receive any significant adverse 
comment on this direct final rule within the specified comment period, 
it will publish a notice in the Federal Register confirming the 
effective date of this final rule within 30 days after the comment 
period on the direct final rule ends and withdraw the notice of 
proposed rulemaking. 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 document in the Federal Register within 30 days after 
the comment period ends and proceed with notice and comment under the 
notice of proposed rulemaking published elsewhere in this issue of the 
Federal Register. 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: The direct final rule is effective on March 12, 2012 unless 
significant adverse comment is received by April 10, 2012. If we 
receive no significant adverse comment within the specified comment 
period, we intend to publish a notice confirming the effective date of 
the final rule in the Federal Register within 30 days after the end of 
the comment period on this direct final rule. If we receive any timely 
significant adverse comment, we will withdraw this final rule in part 
or in whole by publication of a notice in the Federal Register within 
30 days after the comment period ends.

ADDRESSES: You may submit comments, identified by ``RIN 0920-AA47'': by 
any of the following methods:
     Internet: Access the Federal e-rulemaking portal at https://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 DFR.
    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 https://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 https://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 https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: For questions concerning this direct 
final rule: 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 Direct Final Rule
IV. User Fees
V. Services and Activities Covered by User Fees
VI. Analysis of User Fee Charge (Cost to Government)
VII. Payment Instructions
VIII. Regulatory Analysis
IX. References

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 related to this direct final 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. (https://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%) case-fatality rates in humans 
(for an updated

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list see https://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 (76 FR 678), 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 special-permit 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 
single 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 required and in the absence of a viable alternative.

III. Rationale for Direct Final Rule

    Through this Direct Final Rule (DFR), HHS/CDC is establishing a 
user fee to reimburse HHS/CDC for the costs incurred performing these 
tests. Upon the effective date, 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 
antigen-detection 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 will be maintained until further 
notice.
    HHS/CDC has chosen to publish a Direct Final Rule (DFR) because we 
view this as a non-controversial action and anticipate no significant 
adverse

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comment. This DFR does not create any additional requirements or burden 
upon the regulated community. A significant adverse comment is one that 
explains: (1) Why the direct final rule is inappropriate, including 
challenges to the rule's underlying premise or approach; or (2) why the 
direct final rule will be ineffective or unacceptable without a change. 
In determining whether a comment necessitates withdrawal of this direct 
final rule, HHS/CDC will consider whether it warrants a substantive 
response in a notice and comment process. If we receive significant 
adverse comment on this direct final rule, we will publish a timely 
withdrawal in the Federal Register informing the public that the 
amendment in this rule will not take effect. If this DFR is withdrawn, 
we will address all public comments in any subsequent final rule based 
on the Notice of Proposed Rulemaking which is published simultaneously 
in the Federal Register.
    Nothing in this DFR 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 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.

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 (https://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).

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        Table 1--Summary Calculations of User Fee Charge-Per-Test
------------------------------------------------------------------------
                                                                   Costs
                           Components                              (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 high-hazard 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; https://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; https://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 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 direct final 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,

[[Page 6975]]

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 direct final 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 
direct final 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 foreign-based companies in domestic and 
export markets.

D. The Paperwork Reduction Act of 1995

    HHS/CDC has reviewed the information collection requirements of the 
direct final rule and has determined that the information collection 
requested in the direct final rule is already approved by the Office of 
Management and Budget (OMB) under OMB Control No. 0920-0263, expiration 
date 6/30/2014. The direct final 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 direct final rule has been reviewed under Executive Order 
12988, Civil Justice Reform. Under this direct final 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 
direct final 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; 30(4):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., US Policy for Disease 
Control among Imported Nonhuman Primates, J Infect Dis. (1999) 179 
(supplement 1): S281-S282.

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, amend 42 CFR part 71 as 
follows:

PART 71--FOREIGN QUARANTINE

0
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

0
2. In Sec.  71.53, add paragraph (j) to read as follows:


Sec.  71.53  Nonhuman primates.

* * * * *
    (j) Filovirus testing fee. (1) Effective March 12, 2012, non-human 
primate importers shall be charged a fee for filovirus testing of non-
human primate liver samples submitted to the Centers for Disease 
Control and Prevention (CDC).

[[Page 6976]]

    (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. 2012-2843 Filed 2-9-12; 8:45 am]
BILLING CODE 4163-18-P