[Federal Register Volume 72, Number 1 (Wednesday, January 3, 2007)]
[Proposed Rules]
[Pages 92-96]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21723]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 72

RIN 0920-AA03


Interstate Shipment of Etiologic Agents

AGENCY: Centers for Disease Control and Prevention (CDC), HHS.

ACTION: Notice for proposed rulemaking.

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SUMMARY: HHS proposes to remove Part 72 of Title 42, Code of Federal 
Regulations, which governs the interstate shipment of etiologic agents, 
because the U.S. Department of Transportation (DOT) already has in 
effect a more comprehensive set of regulations applicable to the 
transport in commerce of infectious substances. DOT harmonizes its 
transport requirements with international standards adopted by the 
United Nations (UN) Committee of Experts on the Transport of Dangerous 
Goods for the classification, packaging, and transport of infectious 
substances. Rescinding the rule will eliminate duplication of the more 
current DOT regulations that cover intrastate and international, as 
well as interstate, transport. HHS replaced those sections of Part 72 
that deal with select biological agents and toxins with a new set of 
regulations found in Part 73 of Title 42. HHS anticipates that removal 
of Part 72 will alleviate confusion and reduce the regulatory burden 
with no adverse impact on public health and safety.

DATES: Written comments must be received on or before March 5, 2007. 
Written comments on the proposed information collection requirements 
should also be submitted on or before March 5, 2007. Comments received 
after March 5, 2007 will be considered to the extent practicable.

ADDRESSES: You may submit written comments to the following address: 
U.S. Department of Health and Human Services, Centers for Disease 
Control and Prevention, National Center for Infectious Diseases/OD, 
ATTN: Interstate Shipment of Etiologic Agents Comments, 1600 Clifton 
Road, NE (C12), Atlanta, GA 30333. Comments will be available for 
public inspection Monday through Friday, except for legal holidays, 
from 9 a.m. until 5 p.m. at 1600 Clifton Road, NE, Atlanta, GA. Please 
call Ruenell Massey at 404-639 -945 to schedule your visit. Comments 
also may be viewed at http://www.cdc.gov/ncidod/agentshipment/index.htm. You may submit written comments by fax to 404-639-3039, 
Attention: Dr. Janet Nicholson, or electronically via the Internet at 
http://www.regulations.gov. To download an electronic version of the 
rule, you may access http://www.regulations.gov. You must include the 
agency name (Centers for Disease Control and Prevention) and Regulatory 
Information Number (RIN) on all submissions for this rulemaking.

FOR FURTHER INFORMATION CONTACT: Dr. Janet K. Nicholson, National 
Center for Infectious Diseases/OD, Centers for Disease Control and 
Prevention, U.S. Department of Health and Human Services, 1600 Clifton 
Rd., NE (MS-C12), Atlanta GA 30333; telephone: 404-639-3945; e-mail 
[email protected].

SUPPLEMENTARY INFORMATION: Part 72 of Title 42 of the Code of Federal 
Regulations provides minimal requirements for packaging and shipping 
materials, including diagnostic specimens and biological products, 
reasonably believed to contain an etiologic agent. It provides more 
detailed requirements, including labeling, for materials containing 
certain etiologic agents, with a list of the biological agents and 
toxins provided. For agents on the list, the rule requires reporting to 
HHS/CDC damaged packages and packages not received. The rule also 
requires sending certain agents on the list by registered mail or an 
equivalent system.
    The rule, as currently promulgated, is out-of-date, and duplicates 
more current regulations of DOT. Further, the regulation is 
inconsistent with the procedures of other transport governing bodies, 
such as the International Civil Aviation Organization (ICAO) and the 
International Air Transport Association (IATA), for air, and the U.S. 
Postal Service for ground.
    Section 72.6, a major portion of 42 CFR 72 that dealt with select 
agents, was superseded by the issuance of an Interim Final Rule for 42 
CFR 73 on December 13, 2002 (67 FR 76886). Part 73 implements 
provisions of the Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002.
    The continued existence of the remaining provisions of the out-of-
date HHS/CDC regulation is confusing to the packaging and transport 
communities. The provisions serve no useful purpose that merits their 
retention. HHS/CDC will remain available for consultation on and 
response to public-health issues and emergencies, in accordance with 
its normal duties in the interest of public health and safety.

Transition From HHS to DOT Regulations

    DOT has the primary statutory authority to regulate the safe and 
secure transportation of all hazardous materials, including infectious 
materials, shipped in intrastate, interstate, and foreign commerce. The 
etiologic agents covered by 42 CFR 72 are considered to be hazardous 
materials, and, in practice, the DOT regulations, 49 CFR 171-178, have 
superseded since DOT began including more specific regulations on 
infectious substances. The earlier versions of the DOT regulations on 
etiologic agents were based on and virtually identical to the HHS 
regulations. These regulations have been modified over time, as 
necessary, to continue to provide protection for persons who handle 
shipments with as few impediments as possible to quick shipment. In 
1990, DOT authorized the term ``infectious substance'' as synonymous 
with ``etiologic agent.'' In 1991, DOT expanded the definition of 
``etiologic agent'' to include agents listed in 42 CFR 72, plus others 
that cause or could cause severe, disabling or fatal human disease, 
thereby including agents such as human immunodeficiency virus that were 
not on the HHS list. DOT also issued expanded packaging

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requirements at that same time. In 1994 and 1995, DOT worked with other 
Federal agencies (including HHS/CDC, the HHS/Food and Drug 
Administration, the Occupational Safety and Health Administration, and 
the Environmental Protection Agency) to minimize differences between 
the DOT regulations and other Federal regulations on regulated medical 
waste, and to ease compliance and eliminate gaps to assure safety.

UN Recommendations and Model Regulations

    The UN publishes Recommendations on the Transport of Dangerous 
Goods and Model Regulations on a biennial basis. The recommendations 
are developed by the Committee of Experts on the Transport of Dangerous 
Goods of the UN Economic and Social Council. Model Regulations were 
first adopted in December 1996, for the 10th Revised Edition. The 
purpose of the Model Regulations is to present a basic scheme of 
provisions that will allow uniform development of national and 
international regulations that govern the various modes of transport, 
thereby facilitating worldwide harmonization.
    In 1997, the World Health Organization (WHO) published ``Guidelines 
for the Safe Transport of Infectious Substances and Diagnostic 
Specimens,'' prepared by the Directors of WHO Collaborating Centers for 
Biosafety and other advisers to provide practical guidance to 
facilitate compliance with international standards.
    HHS/CDC has a WHO Collaborating Center for Biosafety and Training, 
and has provided consultation to the WHO Secretariat and to the 
Committee of Experts on infectious-substance issues and the development 
of the UN Recommendations and Model Regulations.
    DOT has also worked with the Committee of Experts, and over time 
has harmonized the DOT regulations with the UN Model Regulations.
    In October 2001, the WHO convened a meeting, which included 
infectious-disease and biosafety experts, to consider guidance needed 
for the safe transport of infectious substances, and to identify the 
infectious substances that need to be subject to transport regulation. 
The meeting developed a consensus document, and presented it to the UN 
Committee of Experts. Subsequent deliberations resulted in development 
and publication of the 13th Revised Edition of the UN Model Regulations 
for Transport of Infectious Substances, published in 2004.
    These model regulations recommended a new classification scheme of 
categories A and B, based on risk during transport, instead of 
primarily in the laboratory. The WHO and the Committee of Experts 
assessed the risk of infection by pathogens in the transport setting 
and, with review by HHS/CDC and other public-health experts and 
scientists, refined the list of Category A agents of concern. Category 
A includes ``an infectious substance which is transported in a form 
that, when exposure to it occurs, is capable of causing permanent 
disability, life-threatening or fatal disease to humans or animals.'' 
Category B includes ``an infectious substance which does not meet the 
criteria for inclusion in Category A.'' Packaging requirements were 
clarified and simplified for each category.
    The ``Infectious Substances'' portion of the 14th Revised Edition 
of the UN Model Regulations, adopted in December 2004 and published in 
2005, is very similar to the 13th Edition. The new edition adds a 
definition for ``patient specimens''; adds ``cultures only'' to several 
microorganisms on the infectious-substances list for Category A; 
clarifies shipping names and labeling; and clarifies exemptions from 
regulations.
    In September 2005, the WHO Secretariat published ``Guidance on 
Regulations for the Transport of Infectious Agents'' (WHO/CDS/CSR/LYO/
2005.22) which combined into one document the component parts of the 
13th and 14th Revised Editions.

Harmonization of DOT Regulations With UN/WHO Publications

    The DOT Notice of Proposed Rulemaking (NPRM), published on January 
22, 2001 (66 FR 6941), for public comment, and the final rule, 
published on August 14, 2002 (67 FR 53118), which became effective on 
October 1, 2002, revised definitions and adopted packaging requirements 
consistent with international standards. The DOT final rule 
incorporated new classification criteria (WHO Risk Groups 1-4 at that 
time) for infectious substances, diagnostic specimens, biological 
products, genetically modified organisms and microorganisms, and 
medical wastes--consistent with the 12th Revision of the UN Model 
Regulations of 2001. Among other changes, the final rule revised 
packaging requirements for toxic and infectious substances consistent 
with the international performance standards. HHS/CDC and other 
relevant Federal agencies reviewed the DOT proposals before final 
publication.
    The DOT Notice of Proposed Rulemaking (NPRM), published on May 19, 
2005 (70 FR 29170), further harmonized the DOT regulations with the 
13th and 14th Revised Editions of UN Model Regulations. DOT developed a 
final rule after consideration of comments received from the public, 
including the affected commercial, research, public-health, medical, 
and transport communities, and after discussion with other relevant 
Federal regulating authorities. The final rule was published on June 2, 
2006 (71 FR 32244) and became effective on October 1, 2006.
    The DOT final rule is almost entirely consistent with the UN Model 
Regulations. One non-substantive difference is that the final rule 
retains the definition of ``biological products'' that is more 
consistent with the definition used by HHS/FDA and other Federal 
agencies.

Specimens With Low Likelihood of Pathogens

    Another difference relates to the exemption from regulation of 
human and animal specimens for which there is minimal likelihood that 
pathogens are present. The UN Model Regulations recommend exemption if 
the specimen is transported in a package (three components) that will 
prevent any leakage; is of adequate strength for its capacity, mass, 
and intended use; and is marked as an exempt specimen. The DOT 
regulations do not specify any packaging requirement for these 
specimens with minimal likelihood that pathogens are present.
    The requirement for triple packaging for these specimens, however, 
is included in the requirements issued by other transport-governing 
organizations. The U.S. Postal Service Domestic Mail Manual (DMM) 
requires special packaging (not subject to performance requirements as 
for infectious substances) for liquid diagnostic specimens that would 
not meet the current definitions for a Category A or B infectious 
substance. The packaging is consistent with the packaging recommended 
in the UN Model Regulations, except that for specimens that do not 
exceed 50 ml. the second leak-proof container may serve as the shipping 
container if it has enough strength to withstand ordinary postal 
processing. It is likely these requirements will be revised in time to 
be entirely consistent with the UN Model Regulations. The ICAO 
Technical Instructions (ICAO TI) govern virtually all shipments 
transported internationally by air, and the majority of U.S. domestic 
air shipments.

[[Page 94]]

Addendum No. 2 to ICAO TI (Doc. 9284), issued June 30, 2005, includes 
almost verbatim the language from the UN Model Regulations regarding 
exempt specimens, except that the UN made recommendations for packaging 
and the ICAO TI requires the packaging specifications. IATA does the 
same in Addendum III, posted July 5, 2005, to the 46th Edition of IATA 
Dangerous Goods Regulations. Inclusion of the triple-packaging 
provision by these organizations covers virtually all shipment in 
commerce of routine patient specimens and biological products for which 
there is little likelihood of containing an infectious substance.

Section by Section--Comments on Removal

    HHS provides a section-by-section rationale for removing the 
remaining portions of 42 CFR 72.

Section 72.1 Definitions

    Current definitions consistent with UN/WHO recommendations are 
provided in the DOT rule that applies to intra-state and international 
as well as interstate transport.

Section 72.2 Transportation of Diagnostic Specimens, Biological 
Products, and Other Materials; Minimum Packaging Requirements

    Section 72.2 provided that diagnostic specimens and biologic 
products which the shipper ``reasonably believes may contain an 
etiologic agent'' must be ``packaged to withstand leakage of contents, 
shocks, pressure changes, and other conditions incident to ordinary 
handling in transportation.'' The DOT detailed packaging requirements 
for Categories A and B have superseded this very general requirement. 
The term ``infectious substance'' has replaced ``etiologic agent'' in 
the UN Model Regulations, and in the DOT and other applicable 
regulations. Those regulations define ``infectious substance'' as a 
``material known or reasonably expected to contain a pathogen.''
    The DOT regulations define pathogens into two categories. Category 
A is an ``infectious substance in a form that is capable of causing 
permanent disability or life-threatening or fatal disease in otherwise 
healthy humans or animals when exposure to it occurs.'' Category B is 
an infectious substance that does not meet the criteria for Category A. 
The DOT final rule exempts a ``material that has a low probability of 
containing an infectious substance, or where the concentration of the 
infectious substance is at a level naturally occurring in the 
environment so it cannot cause disease when exposure to it occurs.'' As 
stated above, leak-proof packaging of adequate strength is required for 
these materials by the U.S. Postal Service, ICAO, and IATA. The DOT 
final rule provides for classification and shipping as Category A or B 
a biological product ``known or reasonably expected'' to contain a 
pathogen that meets the criteria for either category, thereby covering 
the same substances as covered by the original intent of section 72.2.
    Further, the HHS rule covered the substances only in transport from 
one State to another or from one State through another State and back 
to the State of origin. The DOT regulations cover transport within 
State, and in international commerce, as well as from State-to-State.

Section 72.3 Transportation of Materials Containing Certain Etiologic 
Agents; Minimum Packaging Requirements

    This section provided a list of specific agents that cannot be 
shipped in interstate traffic, unless packaged, labeled, and shipped in 
accordance with the requirements specified in the section. Neither the 
list of agents, nor the packaging, labeling, and shipping requirements, 
have been kept up-to-date, and have now become outmoded because of the 
extensive process undertaken biennially by the UN Committee of Experts 
on the Transport of Dangerous Goods and the harmonization of the DOT 
regulations with the resultant UN Model Regulations and the WHO 
``Guidance on the Transport of Infectious Substances.'' The HHS/CDC WHO 
Collaborating Center for Biosafety has been a partner in that effort.
    The list included in the June 2, 2006, DOT final rule differs from 
the list in the UN Model Regulations in the 14th Revision in only two 
instances. The DOT list does not include hepatitis B virus (cultures 
only), and it includes ``and other lyssaviruses'' as part of the rabies 
listing. All microorganisms on the DOT list are to be packaged and 
shipped as Category A infectious substances.
    A comprehensive discussion of the new method of categorizing 
substances as Category A or B for purposes of transportation can be 
found in the previously referenced DOT final rule entitled ``Hazardous 
Materials: Infectious Substances; Harmonization with the United Nations 
Recommendations; Final Rule'' (71 FR 32244, June 2, 2006). HHS/CDC 
encourages all persons who are interested in commenting on the 
rescission of 42 CFR 72 to read the DOT final rule for a more 
comprehensive understanding of the new method of categorization, and to 
review the substances in Category A.
    In brief, the UN Committee of Experts on the Transport of Dangerous 
Goods, with input of HHS/CDC, the WHO Secretariat, and others, 
developed a classification scheme more suited for the risks inherent in 
transport as opposed to risks in the laboratory. The previous system of 
four risk groups, with ``4'' as highest risk, was developed primarily 
to protect workers in the laboratory environment. The new Category A 
includes an infectious substance transported in a form that is capable 
of causing permanent disability or life-threatening or fatal disease to 
otherwise healthy humans or animals when exposure to it occurs. It 
includes substances previously categorized in Risk Group 4 and some in 
Risk Groups 2 and 3. Category B includes infectious substances 
(diagnostic or clinical specimens) that do not meet the criteria for 
Category A. The DOT final rule provides a list (not all-inclusive) of 
Category A agents.
    HHS encourages the public to review the current packaging 
requirements provided in the DOT final rule cited above, as well as the 
DOT final rule entitled ``Revisions to Standards for Infectious 
Substances'' published in the Federal Register (67 FR 53118), August 
14, 2002. The requirements are consistent with the requirements adopted 
by the UN, and have been refined over time to be more specific than the 
older HHS requirements, with some liquid-volume changes from those 
specified in 72.2(a)(b). Another example of refinement is that the DOT 
regulations require the outer packaging to release carbon dioxide gas 
when dry ice (72.2(c)) is used, while maintaining structural integrity 
of the package.
    72.3(d) describes a label that is required on the outer shipping 
container for etiologic agents transported in interstate traffic. The 
UN Model Regulations have also described a label that can be recognized 
for transport of these agents anywhere in the world. With harmonization 
of the DOT regulations with the international regulations, the label 
required in this section of the HHS regulation is duplicative, and no 
longer necessary.
    72.3(e) required reporting of damaged packages to HHS. The label 
mentioned above included the statement: ``In case of damage or leakage, 
notify Director CDC,'' and a telephone number was provided. Reporting 
over the years has been sporadic, and has served little direct purpose. 
The attention to the

[[Page 95]]

importance of preventing leakage and preventing exposure has resulted 
in the benefit that most carriers have cleanup procedures in place, and 
most reports are made after the persons involved have followed the 
company procedures for cleanup. Having procedures in place, such as the 
U.S. Postal Service has, is preferable to relying on a call to HHS to 
obtain directions. Moreover, the DOT regulations (at 49 CFR 171.15 and 
171.16) require carriers to report transportation incidents that 
involve infectious substances. Immediate reporting by telephone is 
required for incidents where fire, breakage, spillage, or suspected 
contamination occurs that involves the shipment of infectious 
substances (see 49 CFR 171.15(a)(3)). In addition, a written report is 
required for any unintentional release of hazardous materials from a 
packaging during transportation (see 49 CFR 171.16(a)). Additional 
reporting of incidents to HHS is redundant and unnecessary. The DOT 
regulations permit a carrier to provide telephoned incident reports to 
HHS instead of DOT. For consistency, DOT will amend this provision of 
its regulations after rescission of Part 72.
    DOT regulations require packages that contain infectious substances 
to be labeled to indicate the infectious hazard (see 49 CFR 172.434 for 
a depiction of the required label). The label currently includes this 
statement: ``In case of damage or leakage immediately notify public 
health authority. In USA, notify Director--CDC; Atlanta, GA; 1-800-232-
0124.'' DOT will consider revising the INFECTIOUS SUBSTANCE label after 
rescission of Part 72.
    The WHO ``Guidance on Regulations for the Transport of Infectious 
Substances,'' September 2005, provides specific recommended procedures 
for spill cleanup. This Guidance is available to the agencies that 
govern land and air shipment. The recommended procedures reflect those 
contained in the WHO Laboratory Biosafety Manual, Third Edition, 2004. 
As discussed below, the DOT regulations provide criteria for incident 
reporting. The HHS regulation required reporting of ``damaged 
packages'' without additional criteria for reporting. Nothing will be 
lost by withdrawing this requirement for immediate and routine 
reporting of damaged packages.
    Although routine reporting to HHS will not be required by 
regulation after removal of Part 72, HHS will remain available for 
consultation on and response to public-health issues and emergencies, 
in accordance with its normal duties in the interest of public health 
and safety. As part of this support, HHS will maintain the current 
reporting telephone number on a 7 day/24 hour basis in order to assist 
DOT with the management of suspected exposures.
    HHS/CDC and the HHS/National Institutes of Health are currently 
revising the manual, Biosafety in Microbiological and Biomedical 
Laboratories. The section of the 5th Edition that is related to 
transport of agents is expected to contain general guidelines for the 
cleanup of infectious substances. This section will be useful to 
organizations responsible for transporting packages; having clean-up 
procedures in place is the most important element of response to a 
damaged package.
    72.3(f) Registered mail or an equivalent system. This section lists 
several agents that are required to be shipped by registered mail or an 
equivalent system, with required notification of receipt. All but one 
of these agents (Histoplasma capsulatum) is included on the list of 
select agents and toxins covered by 42 CFR 73. 42 CFR 73 establishes 
more strict requirements for transfer of these agents. The sender and 
recipient must have a certificate of registration for the agent. A form 
is submitted to HHS for approval of the transfer. Packaging and 
shipping must comply with all applicable requirements (Category A for 
these agents), including those of DOT. The recipient must notify the 
sender and HHS of receipt within 2 business days, or of non-receipt 
within 48 hours after expected time of receipt. The requirement for 
registered mail for these agents is no longer applicable.

Section 72.4 Notice of Delivery; Failure to Receive

    This section required notification of the Director of HHS of non-
delivery within five days of expected delivery of the agents listed in 
72.3(f). As stated above, 42 CFR 73 provides more strict notification 
requirements for these agents. Notification is required of non-delivery 
within 48 hours of expected delivery time; also submission of a form 
confirming receipt is required within two business days of receipt of a 
select agent or toxin.
    The amendment published on March 18, 2005 (70 FR 13316), which 
conformed this section to the new 42 CFR 73, is no longer necessary, 
and is removed.

Section 72.5 Requirements; Variations

    This section allowed the Director of HHS to approve variations in 
requirements if protection remains equivalent. No variations have been 
approved that DOT has not also approved. Removal of the rule eliminates 
the basis of necessity for the Director of HHS to have such authority.

Section 72.6 Additional Requirements for Facilities Transferring or 
Receiving Select Agents

    This entire section, 72.6(a)-(j), was replaced or amended by 
publication by HHS in the Federal Register of 42 CFR 73, ``Possession, 
Use, and Transfer of Select Agents and Toxins,'' as Interim Final Rules 
on December 13, 2002 (67 FR 76886), and November 3, 2003 (68 FR 62245), 
and as a Final Rule on March 18, 2005 (70 CFR 13294), with an effective 
date of April 18, 2005.
    These rulemakings also replaced the list of agents at ``Appendix A 
to Part 72--Select Agents,'' as well as the ``Exemptions'' section 
following the Appendix.
    The amendments published on March 18, 2005 (70 FR 13316), which 
conformed section 72.6(h) and Appendix A to 42 CFR 73, are no longer 
needed, and would be removed by this notice of proposed rulemaking.

Section 72.7. Penalties

    Penalties were specified for violations of this part, with stronger 
penalties for violations related to select agents. Similar penalties 
for violations of provisions of part 73 related to select agents have 
been specified by revision to 42 CFR Part 1003--Civil Money Penalties, 
Assessments and Exclusions. The DOT regulations provide for penalty for 
non-compliance, as do ICAO and other entities with instructions or 
regulations regarding transport of infectious substances.

Authority

    The HHS regulation of the interstate transfer of etiologic agents 
is based on the general authority found in Section 264 of Title 42, 
United States Code, Regulations to Control Communicable Diseases, in 
Part G, Quarantine and Inspection.

Regulatory Analyses

    Rescinding Part 72 reduces the regulatory burden on affected 
entities. The DOT Hazardous Materials Transportation regulations and 
the HHS Select Agent regulations already apply, and shippers are 
following them. DOT and HHS have completed the required analyses for 
rules that supersede the rule being removed, and which are already in 
effect. Eliminating this Federal regulation will be beneficial to the 
regulated community by alleviating confusion and duplication.
    HHS does not anticipate the proposed removal to have any impact on 
other

[[Page 96]]

Federal programs involved in transport of materials that are reasonably 
believed to contain infectious substances, such as the HHS/CDC Import 
Permit Program; the HHS/CDC Clinical Laboratories Improvement Program; 
the HHS/CDC Select Agent Program; and various research programs of HHS/
NIH and HHS/FDA and other Agencies. Agencies will need to review and 
update references in their guidance and regulating documents.

Paperwork Reduction Act

    This notice of proposed rulemaking does not impose any new 
information-collection requirements, and does not invoke any issues 
that make it subject to the Paperwork Reduction Act.
    The only impact of removal of 42 CFR 72 is to reduce burden. It 
eliminates specification for a second label to be attached to the outer 
shipping container. This label is no longer needed since it duplicates 
the label recommended by the UN Model Regulations, and adopted by DOT 
and other organizations (such as ICAO, IATA, and the U.S. Postal 
Service) that govern shipments of infectious substances.
    Impact of paperwork previously involved with sections that dealt 
with notice of delivery or failure to receive (72.4) is insignificant 
because HHS has rarely received such paperwork.

Executive Order 12866 and Regulatory Flexibility Act

Executive Order 12866
    Executive Order 12866 directs 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). The Executive 
Order classifies a ``significant regulatory action,'' requiring review 
by the Office of Management and Budget unless OMB waives such review, 
as any regulatory action that is likely to result in a rule that may: 
(1) Have an annual effect on the economy of $100 million or more or 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities; (2) Create a serious inconsistency or interfere with an 
action taken or planned by another agency; (3) Materially alter the 
budgetary impact of entitlements, grants, user fees, or loan programs 
or the rights and obligations of recipients thereof; or (4) Raise novel 
legal or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in the Executive Order.
    The economic, interagency, budgetary, legal, and policy 
implications of this proposed rule have been examined, and the 
regulatory action has been deemed to be ``not a significant regulatory 
action'' under the Executive Order because removal of this regulation 
is not likely to result in a rule that may raise novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in the Executive Order.

Regulatory Flexibility Act

    HHS does not anticipate that this notice of proposed rule making 
will have any economic impact on small businesses and other small 
entities.

Unfunded Mandates

    This notice of proposed rulemaking imposes no mandates, and will 
not result in any expenditure burden, on State, local, or tribal 
governments.

Executive Order 12988

    This notice of proposed rulemaking includes no provisions that 
would lead to burden on the court system.

Executive Order 13132

    This notice of proposed rulemaking does not propose any regulation 
that would preempt State, local and Indian tribe requirements, or that 
would have any substantial direct effects on the States, relationship 
between the national government and the States, or the distribution of 
power and responsibilities among the various levels of government.

Environmental Assessment

    This notice of proposed rule making is not a major regulatory 
action, and will not result in any impact on the environment; transport 
of infectious substances across State lines is comprehensively covered 
by existing regulations of other Agencies.

List of Subjects in 42 CFR Part 72

    Biologics, Hazardous materials transportation, Packaging and 
containers, Penalties, Transportation.

    For the reasons set forth in the preamble under the authority of 42 
U.S.C. 264, 271; 31 U.S.C. 9701; 18 U.S.C. 3559, 3571, and 42 U.S.C. 
262 note, the Department of Health and Human Services proposes to amend 
title 42 (Public Health) of the Code of Federal Regulations by removing 
part 72 (Interstate Shipment of Etiologic Agents).

PART 72--[REMOVED AND RESERVED]

    Dated: July 21, 2006.
Julie Louise Gerberding,
Director, Centers for Disease Control and Prevention.
    Dated: August 21, 2006.
Michael O. Leavitt,
Secretary.

    Editorial Note: This document was received at the Office of the 
Federal Register on December 15, 2006.

 [FR Doc. E6-21723 Filed 12-29-06; 8:45 am]
BILLING CODE 4163-18-P