[Federal Register Volume 78, Number 29 (Tuesday, February 12, 2013)]
[Rules and Regulations]
[Pages 9828-9831]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02825]


=======================================================================
-----------------------------------------------------------------------

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: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Centers for Disease Control and Prevention (CDC), located 
within the Department of Health and Human Services (HHS), is amending 
regulations for the importation of live nonhuman primates (NHPs) by 
establishing 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 are amending the regulations to establish 
a filovirus testing service at HHS/CDC, because

[[Page 9829]]

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.

DATES: This final rule is effective on March 14, 2013.

FOR FURTHER INFORMATION CONTACT: Ashley A. Marrone, J.D., Division of 
Global Migration and Quarantine, Centers for Disease Control and 
Prevention, 1600 Clifton Road NE., Mailstop E-03, Atlanta, Georgia 
30333, telephone, 404-498-1600.

SUPPLEMENTARY INFORMATION: This final rule is organized as follows:

Table of Contents

I. Background
II. Public Comment Summary and Responses
    A. Public Comments of General Support
    B. Public Comments Regarding Analysis of the Rule
III. Alternatives Considered
IV. Payment Instructions
V. Regulatory Analyses
    A. Required Regulatory Analyses under Executive Orders 12866 and 
13563
    B. Regulatory Flexibility Act
    C. Small Business Regulatory Enforcement Fairness Act of 1996
    D. Paperwork Reduction Act of 1995
    E. National Environmental Policy Act (NEPA)
    F. Civil Justice Reform (Executive Order 12988)
    G. Executive Order 13132 (Federalism)
    H. Plain Language Act of 2010

I. Background

    On February 10, 2012, we published a notice of proposed rulemaking 
(NPRM) in the Federal Register (77 FR 7109) that provided the 
background, rationale, description of the services and activities 
covered by the user fee, an analysis of the user fee charge (cost to 
the government), and payment instructions. On the same date, we 
published a companion Direct Final Rule (DFR) (77 FR 6981). In both the 
NPRM and DFR, we stated that if we did not receive any significant 
adverse comments by April 10, 2012, we would publish a document in the 
Federal Register withdrawing the NPRM and confirming the effective date 
of the DFR within 30 days after the end of the comment period.
    Because the DFR contained an error in effective date and HHS/CDC 
received a significant adverse public comment, we published a 
correcting amendment in the Federal Register on June 15, 2012 (77 FR 
35878), withdrawing the DFR.

II. Public Comment Summary and Responses

    HHS/CDC received four public comments on the NPRM. Three of the 
commenters expressed strong support for the proposal, and one commenter 
questioned our analysis of the rule. HHS/CDC did not receive any public 
comments objecting to the amount of the user fee, which is $540.00 USD. 
The comments and HHS/CDC responses are summarized below.

A. Public Comments of General Support

    One commenter indicated that the user fees would be a good idea 
because the testing of nonhuman primate liver samples for filovirus 
infection is essential for public health and safety. The commenter 
stated that the amount of the user fee is not exorbitant and will allow 
the government to continue to test NHPs. This commenter also expressed 
concern that the agency would be unable to continue to test NHPs absent 
reimbursement. Finally, the commenter indicated his/her support for the 
testing of animals that pose a threat to human life. A second commenter 
noted that it is the duty of the federal government to protect the 
health and welfare of its citizens from preventable dangers and that 
failure to do so would constitute a dereliction of duty. Further, this 
commenter fully supported what he/she referred to as a ``reasonable 
fee.''
    HHS/CDC Response. HHS/CDC thanks the commenters for their comments.
    A third commenter agreed that establishing user fees for filovirus 
testing of nonhuman primate liver samples was a necessary step toward 
protecting public health. While this commenter offered ``100%'' support 
for the regulation, the commenter also questioned whether HHS/CDC's 
costs for storing records could increase the amount of the user fee in 
the future.
    HHS/CDC Response. Although HHS/CDC has only recently begun to offer 
this testing service, it has collected and maintained filovirus test 
results from importers since the beginning of the testing requirement 
and expects to continue do so in the future. Because maintaining test 
results are an expense that HHS/CDC had already assumed, these costs 
were not included in the calculations of the user fee. HHS/CDC does not 
expect to attempt to recoup these costs in the future.

B. Public Comments Regarding Analysis of the Rule

    A commenter stated that CDC did not provide an analysis of the 
filovirus testing market, including the nature and extent of current 
and future demand for filovirus testing. The commenter requested that 
HHS/CDC consider and address the long-term prospects of the filovirus 
testing market. Specifically, the commenter stated that if the market 
is minimal, it would be appropriate for the government to administer 
and perform the testing. On the other hand, if the market was much 
larger, then it may be in the interest of the public and the government 
to incentivize the construction of private laboratory facilities for 
the purpose of filovirus testing, thereby allowing the commercial 
market to serve the need of importers.
    HHS/CDC Response. HHS/CDC disagrees with this comment. While not 
labeled specifically as a market analysis in the NPRM, the components 
of a market analysis were included in the preamble of the NPRM. Demand 
and market size, as calculated by revenues and numbers of requests for 
filovirus tests, were included in section III ``Rationale for 
Proposal'' of the NPRM and were based on the observed demand noted by, 
and fees charged by, the commercial laboratory that performed this 
service since 1990.
    In section VI ``Analysis of User Fee Charge (Cost to the 
Government)'' of the NPRM, HHS/CDC noted that during the past five 
years, our records indicated that there were approximately 100-150 
requests per year, generating revenues of $50,000 to $75,000 a year.
    The issue of future demand was also implicitly addressed in the 
NPRM, where we noted that the demand for testing is driven by 
government requirements and the population of imported NHPs that drive 
the demand is limited by regulation to scientific, exhibition or 
educational purposes. Thus, we do not expect that market size and 
demand will change substantially in the long run.
    Regarding the commenter's query about the size of the market, we 
note that regardless of whether the filovirus testing market is 
measured by requests (100-150) or revenues ($50,000 to $75,000 a year), 
it is, and will continue to be, a small market from a laboratory 
perspective. The market revenue generated by testing is too small to 
create demand specifically for a ``filovirus testing facility'' because 
laboratories, especially the Biosafety Level 4 (BSL-4) laboratories 
needed for this type of testing, require large amounts of sunk capital. 
In this context, ``sunk capital'' is intended to mean investments in 
laboratory-specific equipment and facilities that cannot be resold for 
other businesses or used for other purposes. As explained in the NPRM, 
the testing procedure requires a BSL-4 laboratory for specimen 
processing, reagent preparation, and the testing procedure. The 
forecast revenues from filovirus testing of $50,000 to

[[Page 9830]]

$75,000 a year would only be a fraction of the budget needed to sustain 
a BSL-4 type of facility needed to test for filoviruses.
    We note that the estimates in the NPRM of a per-test cost of 
$540.00 USD do not take into account the perspective of a commercial 
laboratory that would trade the costs and benefits of devoting 
laboratory space and resources to filovirus testing for other revenue-
generating tests and services they could offer. Finally, we note that 
no commercial entities have entered the market of antigen-capture 
filovirus testing since the original commercial laboratory stopped 
providing this service.
    Viewed as a whole, these factors (sunk capital required to perform 
such testing, limited market demand, and current lack of a commercial 
laboratory offering this service), were instrumental in shaping our 
view that there is likely no commercial laboratory that will enter this 
market in the immediate future. However, as indicated in the NPRM, 
nothing in this final rule prohibits a commercial laboratory from 
entering the market in the future.
    Next, the commenter raised a series of questions regarding long run 
actions that CDC can take to make filovirus testing viable 
commercially. Specifically, the commenter said, ``it may be more 
appropriate to examine the data and other indicators to ensure that the 
agency is not overlooking any externalities.''
    HHS/CDC Response. As noted in the NPRM, there are no private 
laboratories engaged in filovirus testing at this time. If HHS/CDC were 
to provide the tests free-of-charge, this would be a long-term 
disincentive for any commercial lab to enter the business because no 
commercial lab could compete with no-fee testing. By implementing a 
fee, CDC is eliminating the nature of unfair government competition 
created by a price that may be below standard commercial market fees, 
or free. The fee HHS/CDC intends to charge is consistent with the fee 
previously charged by the one commercial laboratory performing this 
type of testing. Furthermore, as HHS/CDC stated in the NPRM and above, 
the action taken in this rulemaking is not intended to prohibit a 
private sector facility from developing the capability and offering 
this same service in the future. When considered together, the fee, the 
extensive investments needed to build and maintain BSL-4 type 
laboratories, and the small size of the filovirus testing market, 
indicate that CDC can take no other short-term or long-term actions to 
encourage a private market for filovirus testing.

III. Alternatives Considered

    As stated earlier in the Preamble, HHS/CDC believes this testing is 
essential to protect public health and safety. If this testing is not 
provided, it will have a disruptive impact on imports of NHPs for 
science, educational, and exhibition purposes, that would remain in 
quarantine absent a negative test result.
    When HHS/CDC learned that the sole commercial laboratory performing 
this testing was no longer offering the testing, we considered several 
alternatives to meet the testing requirement. One alternative was to 
wait for another commercial laboratory to begin performing the testing. 
However, as stated previously in the Preamble, another laboratory has 
not entered the market since the previous laboratory stopped performing 
this testing. Indeed, to date, no laboratory has begun offering this 
service in response to the NPRM.
    Another alternative that HHS/CDC considered was to perform the 
testing in HHS/CDC laboratories at no cost. However, as commenters have 
noted, the cost burden of performing the testing without compensation 
may prevent the Agency from performing the testing indefinitely. 
Further, as we stated previously in the Preamble, should HHS/CDC offer 
this testing at no charge, it would create a disincentive to the 
private sector to enter the market.
    Finally, HHS/CDC considered offering a filovirus testing service 
and establishing a user fee to cover the cost of the testing. This is 
the alternative that HHS/CDC chose.

IV. Payment Instructions

    As of the effective date of this rule, 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.

V. Regulatory Analyses

A. Required Regulatory Analyses Under Executive Orders 12866 and 13563

    We have examined the impacts of the 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, 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 strongly 
encourage them to do so.
    This rule is being treated as ``not significant'' under EO 12866. 
We are amending 42 CFR 71.53 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. 
Thus, the rule has not been reviewed by the Office of Management and 
Budget (OMB).

B. Regulatory Flexibility Act

    We have examined the impacts of the 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 (RFA), 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 
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.

[[Page 9831]]

D. The Paperwork Reduction Act of 1995

    HHS/CDC has reviewed the information collection requirements of the 
final rule and has determined that the information collection requested 
in the final rule is already approved by the Office of Management and 
Budget (OMB) under OMB Control No. 0920-0263, expiration date June 30, 
2014. The 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 final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. Under this 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/CDC attempted to use plain 
language in promulgating this rule consistent with the Federal Plain 
Writing Act guidelines and requested comment from the public on this 
topic. HHS/CDC did not receive any public comment to this request.

List of Subjects in 42 CFR Part 71

    Communicable diseases, Public health, Quarantine, Reporting and 
recordkeeping requirements, User fees, Testing.
    For the reasons discussed in the preamble, the Centers for Disease 
Control and Prevention amends 42 CFR part 71 as follows:

PART 71--FOREIGN QUARANTINE

0
1. The authority citation for 42 CFR part 71 continues to read as 
follows:

    Authority: Sec. 311 of the Public Health Service (PHS) Act, as 
amended (42 U.S.C. 243), secs. 361-369, PHS Act, as amended (42 
U.S.C. 264-272).

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) 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).
    (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: February 4, 2013.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2013-02825 Filed 2-11-13; 8:45 am]
BILLING CODE P