Establishment of User Fees for Filovirus Testing of Nonhuman Primate Liver Samples, 9828-9831 [2013-02825]

Download as PDF 9828 Federal Register / Vol. 78, No. 29 / Tuesday, February 12, 2013 / Rules and Regulations PART 51—REQUIREMENTS FOR PREPARATION, ADOPTION, AND SUBMITTAL OF IMPLEMENTATION PLANS 1. The authority citation for part 51 continues to read as follows: ■ Authority: 42 U.S.C. 7401, 7411, 7412, 7413, 7414, 7470–7479, 7501–7508, 7601, and 7602. § 51.100—[Amended] 2. Section 51.100 is amended at the end of paragraph (s)(1) introductory text by removing the words ‘‘methyl acetate, 1,1,1,2,2,3,3-heptafluoro-3-methoxypropane (n-C3F7OCH3, HFE–7000), 3ethoxy- 1,1,1,2,3,4,4,5,5,6,6,6dodecafluoro-2-(trifluoromethyl) hexane (HFE–7500), 1,1,1,2,3,3,3heptafluoropropane (HFC 227ea), methyl formate (HCOOCH3), (1) 1,1,1,2,2,3,4,5,5,5-decafluoro-3methoxy-4-trifluoromethyl-pentane (HFE–7300); propylene carbonate; dimethyl carbonate; trans-1,3,3,3tetrafluoropropene; and perfluorocarbon compounds which fall into these ■ classes:’’ and adding in their place the words ‘‘methyl acetate; 1,1,1,2,2,3,3heptafluoro-3-methoxy-propane (nC3F7OCH3, HFE–7000); 3-ethoxy1,1,1,2,3,4,4,5,5,6,6,6-dodecafluoro-2(trifluoromethyl) hexane (HFE–7500); 1,1,1,2,3,3,3-heptafluoropropane (HFC 227ea); methyl formate (HCOOCH3); 1,1,1,2,2,3,4,5,5,5-decafluoro-3methoxy-4-trifluoromethyl-pentane (HFE–7300); propylene carbonate; dimethyl carbonate; trans-1,3,3,3tetrafluoropropene; HCF2OCF2H (HFE– 134); HCF2OCF2OCF2H (HFE–236cal2); HCF2OCF2CF2OCF2H (HFE–338pcc13); HCF2OCF2OCF2CF2OCF2H (H-Galden 1040x or H-Galden ZT 130 (or 150 or 180)); and perfluorocarbon compounds which fall into these classes:’’. Approval and Promulgation of Implementation Plans; New Mexico; Albuquerque/Bernalillo County: Infrastructure and Interstate Transport Requirements for the 1997 and 2008 Ozone and the 1997 and 2006 PM2.5 NAAQS [FR Doc. 2013–03057 Filed 2–11–13; 8:45 am] § 52.1620 BILLING CODE 6560–50–P Due to an error in the EPA approval date, the table entitled ‘‘EPA– APPROVED ALBUQUERQUE/ BERNALILLO COUNTY, NM REGULATIONS’’ on pages 58034 and 58035 is being reprinted in its entirety to read as follows: ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA–R06–OAR–2009–0648; FRL–9728–7] Correction In rule document 2012–22975 beginning on page 58032 in the issue of Wednesday, September 19, 2012, make the following corrections: ■ [Corrected] EPA-APPROVED ALBUQUERQUE/BERNALILLO COUNTY, NM REGULATIONS State citation State approval/effective date Title/subject EPA approval date Explanation New Mexico Administrative Code (NMAC) Title 20—Environment Protection, Chapter 11—Albuquerque/Bernalillo County Air Quality Control Board * * Part 8 (20.11.8 NMAC) ........... * * * Ambient Air Quality Standards. * Part 61 (20.11.61 NMAC) ....... * * * 8/12/2009 * * * [FR Doc. C1–2012–22975 Filed 2–11–13; 8:45 am] BILLING CODE 1505–01–D 1/10/2011 * DEPARTMENT OF HEALTH AND HUMAN SERVICES pmangrum on DSK3VPTVN1PROD with RULES RIN 0920–AA47 Establishment of User Fees for Filovirus Testing of Nonhuman Primate Liver Samples Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). AGENCY: Jkt 229001 PO 00000 Frm 00052 Fmt 4700 * * ACTION: * Final rule. 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 31day quarantine period for any reason other than trauma. We are amending the regulations to establish a filovirus testing service at HHS/CDC, because SUMMARY: [Docket No. CDC–2012–0002] 15:05 Feb 11, 2013 * September 19, 2012, [Insert FR page number where document begins]. 42 CFR Part 71 VerDate Mar<15>2010 * September 19, 2012, [Insert FR page number where document begins]. * Prevention of Significant Deterioration. * * Sfmt 4700 E:\FR\FM\12FER1.SGM 12FER1 Federal Register / Vol. 78, No. 29 / Tuesday, February 12, 2013 / Rules and Regulations 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 pmangrum on DSK3VPTVN1PROD with RULES 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 VerDate Mar<15>2010 15:05 Feb 11, 2013 Jkt 229001 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 PO 00000 Frm 00053 Fmt 4700 Sfmt 4700 9829 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 E:\FR\FM\12FER1.SGM 12FER1 pmangrum on DSK3VPTVN1PROD with RULES 9830 Federal Register / Vol. 78, No. 29 / Tuesday, February 12, 2013 / Rules and Regulations $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 revenuegenerating 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 nofee 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 VerDate Mar<15>2010 15:05 Feb 11, 2013 Jkt 229001 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 PO 00000 Frm 00054 Fmt 4700 Sfmt 4700 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 foreignbased companies in domestic and export markets. E:\FR\FM\12FER1.SGM 12FER1 Federal Register / Vol. 78, No. 29 / Tuesday, February 12, 2013 / Rules and Regulations 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. pmangrum on DSK3VPTVN1PROD with RULES 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 VerDate Mar<15>2010 15:05 Feb 11, 2013 Jkt 229001 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 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 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: 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 PO 00000 Frm 00055 Fmt 4700 Sfmt 4700 9831 DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 67 [Docket ID FEMA–2013–0002] Final Flood Elevation Determinations Federal Emergency Management Agency, DHS. ACTION: Final rule. AGENCY: Base (1% annual-chance) Flood Elevations (BFEs) and modified BFEs are made final for the communities listed below. The BFEs and modified BFEs are the basis for the floodplain management measures that each community is required either to adopt or to show evidence of being already in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). SUMMARY: The date of issuance of the Flood Insurance Rate Map (FIRM) showing BFEs and modified BFEs for each community. This date may be obtained by contacting the office where the maps are available for inspection as indicated in the table below. ADDRESSES: The final BFEs for each community are available for inspection at the office of the Chief Executive Officer of each community. The respective addresses are listed in the table below. FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646–4064, or (email) Luis.Rodriguez3@fema.dhs.gov. DATES: The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the modified BFEs for each community listed. These modified elevations have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Deputy Associate Administrator for Mitigation has resolved any appeals resulting from this notification. This final rule is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60. SUPPLEMENTARY INFORMATION: E:\FR\FM\12FER1.SGM 12FER1

Agencies

[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]


=======================================================================
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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]
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