Foreign Quarantine; Etiological Agents, Hosts, and Vectors, 63891-63896 [2011-26656]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 76, Number 199 (Friday, October 14, 2011)]
[Proposed Rules]
[Pages 63891-63896]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26656]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 71

[Docket No. CDC-2011-0007]
RIN 0920-AA37


Foreign Quarantine; Etiological Agents, Hosts, and Vectors

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Centers for Disease Control and Prevention (CDC) within 
the U.S. Department of Health and Human Services (HHS) is issuing this 
Notice of Proposed Rulemaking (NPRM) to revise the regulations that 
cover the importation of etiological agents and the hosts and vectors 
of human disease. The changes are proposed to improve CDC's ability to 
prevent the introduction, transmission, or spread of communicable 
diseases into the United States.

DATES: To be assured consideration, comments must be received on or 
before December 13, 2011. Comments received after the close of the 
comment period will be considered to the fullest extent possible.

ADDRESSES: You may submit comments, identified by Regulatory 
Information Number (RIN) 0920-AA37 in the heading of this document, by 
any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     E-mail: SAPcomments@cdc.gov. Please include the RIN number 
in the subject line of the message.
     Fax: 404-718-2093.
     Mail: Division of Select Agents and Toxins, Centers for 
Disease Control and Prevention, ATTN: Importation Regulations, 1600 
Clifton Road, NE., MS A-46, Atlanta, Georgia 30333.
     Hand Delivery/Courier: Division of Select Agents and 
Toxins, Centers for Disease Control and Prevention, ATTN: Importation 
Regulations, 1600 Clifton Road, NE., MS A-46, Atlanta, Georgia 30333.
    Instructions: All submissions received must include the agency name 
and RIN for this rulemaking. All relevant comments received will be 
posted without change to https://www.regulations.gov, including any 
personal information provided.
    Docket: For access to the docket to read background documents or 
comments received or to download an electronic version of the NPRM, go 
to https://www.regulations.gov. Comments will be available for public 
inspection Monday through Friday, except for legal holidays, from 9 
a.m. until 5 p.m. at 1600 Clifton Road, NE., Atlanta, GA 30333. Please 
call ahead to 1-866-694-4867 and ask for a representative in the 
Division of Select Agents and Toxins to schedule your visit. Our 
general policy for comments and other submissions from members of the 
public is to make these submissions available for public viewing on the 
Internet as they are received and without change.

FOR FURTHER INFORMATION CONTACT: Robbin Weyant, PhD, Director, Division 
of Select Agents and Toxins, Centers for Disease Control and 
Prevention, 1600 Clifton Road, NE., MS A-46, Atlanta, GA 30333. 
Telephone: 404-718-2000.

SUPPLEMENTARY INFORMATION: The Preamble to this notice of proposed 
rulemaking is organized as follows:

I. Background
    A. HHS/CDC Authority
II. Proposed Changes to 42 CFR 71.54
    A. Section Heading & Definitions
    B. Biosafety and Inspection Provisions

[[Page 63892]]

    C. Permit Exemptions
    D. Transportation
    E. Appeals Process
III. Required Regulatory Analyses and Executive Order 12866, and the 
Regulatory Flexibility Act
IV. Other Administrative Requirements
    A. Paperwork Reduction Act of 1995
    B. Executive Order 12988, Civil Justice Reform and Executive 
Order 13132, Federalism
    C. Plain Language in Government Writing

I. Background

A. HHS/CDC Authority

    This NPRM is proposed under the authority of section 361 of the 
Public Health Service Act (PHS Act) (42 U.S.C. 264). This provision 
authorizes the Health and Human Services (HHS) Secretary to make and 
enforce such regulations as in her judgment are necessary to prevent 
the introduction, transmission, or spread of communicable diseases from 
foreign countries into the States or possessions of the United States 
and from one State or possession into any other State or possession. 
For purposes of carrying out and enforcing such regulations, the HHS 
Secretary may authorize a variety of public health measures, including 
inspection, fumigation, disinfection, sanitation, pest extermination, 
destruction of animals or articles found to be sources of dangerous 
infection to human beings, and other measures.
    The Foreign Quarantine regulations (42 CFR part 71) set forth 
provisions to prevent the introduction, transmission, and spread of 
communicable disease from foreign countries into the United States. 
Part 71, Subpart F (Importations) contains provisions for importation 
of etiological agents, hosts, and vectors (42 CFR 71.54), requiring 
persons to obtain a permit issued by the CDC before importing or 
distributing after import of these materials.

II. Proposed Changes to 42 CFR 71.54

    This document proposes to revise the regulations that cover the 
importation of etiological agents and the hosts and vectors of human 
disease (42 CFR 71.54) as described below. We will consider comments 
that are received within 60 days of publication of this notice in the 
Federal Register.

A. Section Heading and Definitions

    The heading for 42 CFR 71.54 would be changed from ``Etiological 
agents, hosts, and vectors.'' to ``Import Regulations for Infectious 
Biological Agents, Infectious Material, and Vectors'' to clarify 
proposed changes discussed below. Under the proposed changes, only the 
following infectious biological agents, materials, and vectors would 
require a permit issued by the CDC Director prior to entry into the 
United States, or subsequently being transferred within the United 
States:
    Infectious biological agent. A microorganism (including, but not 
limited to, bacteria (including rickettsiae), viruses, fungi, or 
protozoa) or prion, whether naturally occurring, bioengineered, or 
artificial, or a component of such microorganism or prion that is 
capable of causing communicable disease in a human.
    Infectious material. Any material which is known or suspected to 
contain a biological agent infectious to humans.
    Vector. Any animals (vertebrate or invertebrate) including 
arthropods or any noninfectious self-replicating system known to 
transfer or capable of transferring an infectious biological agent to a 
human (e.g., a mosquito).
    We also propose to remove the term ``host'' because we believe 
``host'' means the same as the current proposed definition for 
``vector.'' However, CDC is interested in comments concerning the 
removal of the term ``host'' from the proposed language. CDC is also 
interested in comments concerning the scope of the definition for 
``vector'' and whether it should be limited in some manner to exclude 
animals intended to be exhibited in zoos or mounted animals or hides 
intended for museum displays while remaining broad enough to include 
mosquitoes that carry the malaria parasite Plasmodium between humans.

B. Biosafety and Inspection Provisions

    The key principle in selecting the appropriate safeguards for the 
conduct of the microbiological research is ``risk assessment.'' Risk 
assessment is a process used to identify the hazardous characteristics 
of a known infectious agent or potentially infectious agent or 
material, the activities that can result in exposure to such an agent, 
the likelihood that such exposure will cause a laboratory-acquired 
infection (LAI), and the probable consequences of such an infection. 
The information identified through risk assessment is used to guide the 
selection of appropriate microbiological practices, safety equipment, 
and facility safeguards (biosafety measures) that, when used properly, 
can prevent exposures and dramatically reduce the incidence of LAIs. 
Risk assessment is a common first step in an overall risk-management 
process.
    The safe possession and work with infectious biological agents, 
infectious material, and vectors requires that importers have the 
appropriate biosafety measures in place for imported material. 
Accordingly, CDC proposes that import regulations clearly state that 
the applicant have biosafety measures that are commensurate with the 
hazard posed by the infectious biological agent, infectious material, 
and/or vector to be imported, and the level of risk given its intended 
use. These biosafety measures may be entity-wide, laboratory-specific, 
or agent-specific. CDC believes importers engaged in microbiological 
research and related activities utilizing safe laboratory practices, 
safety equipment, and facility safeguards will reduce the incidence of 
LAIs and other incidents and will protect the public health and 
environment.
    In developing the appropriate biosafety measures, importers working 
with infectious biological agents, infectious material, and vectors 
should use the appropriate microbiological practices, safety equipment, 
and facility safeguards that, when used properly, can prevent exposures 
and dramatically reduce the incidence of LAIs. An applicant should 
consider: (1) The CDC/National Institutes of Health (NIH) publication, 
``Biosafety in Microbiological and Biomedical Laboratories'' (BMBL), 
including all appendices. Copies may be obtained at the CDC Web site at 
https://www.cdc.gov/ and (2) The ``NIH Guidelines for Research Involving 
Recombinant DNA Molecules (NIH Guidelines).'' Copies may be obtained 
from the NIH Web site at https://oba.od.nih.gov/rdna/nih_guidelines_oba.html.
    To implement CDC's inspection authority as provided under 42 U.S.C. 
264(a), CDC proposes that prior to CDC issuing a permit, it may inspect 
the applicant's facility to evaluate whether the importer's 
implementation of its biosafety measures (e.g., physical structure and 
features of the facility, and operational and procedural safeguards) 
are effective and commensurate with the risk posed by the infectious 
biological agent, infectious material, and/or vector, and the level of 
risk given its intended use. CDC will use the following specific 
criteria to determine which entities are to be inspected--(1) 
facilities that request to perform research with imported agents that 
would need to be conducted in a biosafety level (BSL)-3, BSL-4, Animal 
biosafety level (ABSL)-3, ABSL-4 or BSL-3 Agriculture laboratory as 
described in the BMBL (e.g., Mycobacterium tuberculosis), and (2) that 
have not been inspected by CDC's Select Agent Program.
    Even though CDC is proposing that the import regulations 
specifically state a requirement for appropriate biosafety measures as 
a prerequisite for the

[[Page 63893]]

issuance of a permit, we believe, based on our experience with import 
permit submissions addressing the capabilities of the receiving 
laboratories, that most, if not all, importers of etiological agents 
already have written biosafety plans. Based on permit applications 
submitted to CDC between March 1, 2011, and July 22, 2011, the total 
number of applicants with adequate written biosafety plans was 632 out 
of 644 or 98%. Based on the content of those plans, CDC is confident 
that each of them would meet the requirement for appropriate biosafety 
measures of this NPRM. If an importer's biosafety measures were found 
to be inadequate, CDC would offer to work with the entity to address 
any biosafety issues prior to denying the permit.

C. Permit Exemptions

Select Agents and Toxins
    Currently, in accordance with 9 CFR part 121 and 42 CFR part 73 
(Select Agent Regulations), only individuals or entities registered 
with the CDC or U.S. Department of Agriculture, Animal and Plant Health 
Inspection Service's (APHIS') Select Agent Program can legally import 
select agents (i.e., biological agents and toxins that could pose a 
severe threat to public health and safety) into the United States. A 
select agent may only be imported under the conditions described in 9 
CFR 121.16 and 42 CFR 73.16 and must be authorized by APHIS or CDC 
prior to importation. Therefore, we are proposing that importation of 
select agents in accordance with the Select Agent Regulations be 
exempted from the requirement to have an additional import permit under 
42 CFR 71.54.
Diagnostic Specimens
    As defined by the proposed rule, a diagnostic specimen is any 
specimen of human or animal matter (including tissue, blood, body 
discharges, fluids, excretions or similar material), or an 
environmental sample. CDC's policy regarding diagnostic specimens is 
that only diagnostic specimens that are known to contain, or are 
suspected of containing, an infectious biological agent require a 
permit issued by the CDC Director prior to entry into the United States 
or subsequent transfer within the United States. CDC proposes to 
clarify this policy in the regulation by adding a provision that a 
permit is not required for a diagnostic specimen not known by the 
importer to contain, or suspected by the importer of containing, an 
infectious biological agent and the specimen is accompanied by an 
importer certification statement confirming that the material is not 
known or suspected to contain an infectious biological agent. Importers 
would not be required to perform confirmatory tests on these specimens, 
only certify in writing that they have no reason to believe that the 
samples contain an infectious biological agent. Examples of these types 
of diagnostic specimens not known by the importer to contain, or 
suspected by the importer of containing, an infectious biological agent 
may include urine samples submitted for urine drug screens or serum 
samples submitted for cholesterol testing.
Genomic Material
    Genomic material from infectious biological agents can consist of 
Deoxyribonucleic acid (DNA) or Ribonucleic acid (RNA). The nucleic acid 
comprising the genome may be single-stranded or double-stranded, and in 
a linear, circular or segmented configuration. Single-stranded viral 
genomes may be positive sense (same polarity as mRNA), negative sense, 
or ambisense (mixture of the two). Viral genomes which consist of 
positive sense RNA are infectious when the purified viral RNA is 
applied to permissive cells in the absence of any viral proteins. In 
some cases, viral genomes which are composed of double-stranded DNA are 
also infectious (e.g., genome of Cercopithecine Herpesvirus 1 (Herpes B 
virus)). If genomic material being imported does not encode for 
infectious and/or replication competent forms of an infectious 
biological agent then a permit is not required. For example, a permit 
would not be required for RNA obtained from negative stranded RNA 
viruses or for genomic DNA isolated from bacteria. As such, CDC 
proposes to clarify this policy by adding a provision in the regulation 
that a permit is not required for nucleic acids that cannot produce 
infectious forms of any infectious biological agent and the specimen is 
accompanied by an importer certification statement confirming that the 
material is not known to contain or suspected of containing an 
infectious biological agent. Importers would not be required to perform 
confirmatory tests on these specimens, only certify in writing that 
they have no reason to believe that the samples can produce infectious 
forms of any infectious biological agent.
Regulated Products
    CDC proposes to exempt material contained in certain products from 
the requirement to obtain a CDC Permit for importation into the United 
States or subsequent transfer within the United States. If the material 
is contained in a product that is cleared, approved, licensed, or 
authorized under the provisions of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 301 et seq.), Section 351 of the Public Health Service 
Act pertaining to biological products (42 U.S.C. 262), or the Virus-
Serum-Toxin Act (21 U.S.C. 151-159), CDC has determined that it is 
unlikely that material in these products would present a risk of the 
introduction, transmission, or spreading of a communicable disease. 
This exemption would include all investigational products for which an 
Investigational New Drug application (IND) is in place with the U.S. 
Food and Drug Administration (FDA). Examples of products that have been 
cleared, approved, licensed, or authorized by the FDA include FDA-
licensed live attenuated vaccines and diagnostic test kits authorized 
for marketing or investigational use. Examples of products for Section 
351 of the Public Health Service Act pertaining to biological products 
(42 U.S.C. 262) or the Virus-Serum-Toxin Act (21 U.S.C. 151-159) 
include vaccines, antibody products, and blood products.
    CDC proposes to clarify this policy by adding a provision in the 
regulation that a permit is not required for a product that is cleared, 
approved, licensed, or is otherwise authorized under the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 301 et seq), Section 351 of the 
Public Health Service Act pertaining to biological products (42 U.S.C. 
262), or the Virus-Serum-Toxin Act (21 U.S.C. 151-159).

D. Transportation

    During the importation of the infectious biological agents, 
infectious material, or vectors, the importer must be in compliance 
with all applicable laws concerning the packaging and shipment of 
infectious substances, including the following:
     Agriculture (9 CFR parts 92, 94, 95 96, 121, 122, and 
130),
     Occupational Health and Safety Administration (29 CFR 
1910.1030),
     Transportation (49 CFR parts 171 through 180), and
     Postal Service (39 CFR part 111).

As such, CDC proposes to clarify this policy by adding the language 
``The importer is in compliance with all applicable laws concerning the 
packaging and shipment of infectious substances'' at Sec.  71.54(b)(4).

E. Appeals Process

    Since 2003, CDC has denied 2 applications for permits. CDC proposes 
to provide applicants with an opportunity for a written appeal in the

[[Page 63894]]

event that the CDC Director denies a request for a permit to import 
infectious biological agents, infectious material, or vectors under 
this part. Under the proposal, an applicant who wishes to make such an 
appeal would have 30 calendar days after receiving the denial to submit 
the appeal in writing to the CDC Director. The appeal must state the 
factual basis for the appeal and provide any supporting documentations 
to justify the appeal (e.g., documents that demonstrate the facility 
has the appropriate biosafety measures in place for working safely with 
requested imported material). CDC would then issue a written response, 
which would then constitute final agency action. CDC invites comments 
on this process.

F. Alternatives Considered

    In researching the proposed changes, we reviewed how U.S. 
Department of Agriculture/Animal and Plant Health Inspection Service 
(USDA/APHIS) regulates the importation plant and animal products and 
the Federal Select Agent Program regulates the possession, use, and 
transfer of select agents and toxins. We learned that HHS/CDC 
identified, through its Select Agent Program inspection program, 
specific biosafety measure implementation issues in 81 of the 316 the 
entities inspected by CDC since 2003. Some of the biosafety measure 
implementation issues were serious enough to require the suspension of 
registration or other restrictions on biological work at these 
facilities. USDA/APHIS has identified similar biosafety issues.
    Thus, in the proposed rule, import regulations clearly state that 
the applicant have biosafety measures that are commensurate with the 
hazard posed by the infectious biological agent, infectious material, 
and/or vector to be imported, and the level of risk given its intended 
use. The safe possession and work with infectious biological agents, 
infectious material, and vectors requires that importers have the 
appropriate biosafety measures in place for imported material. These 
biosafety measures may be entity-wide, laboratory-specific, or agent-
specific. HHS/CDC believes importers engaged in microbiological 
research and related activities utilizing safe laboratory practices, 
safety equipment, and facility safeguards will reduce the incidence of 
LAIs and other incidents and will protect the public health and 
environment. HHS/CDC also considered a requirement that the applicant 
must develop and implement a written biosafety plan that is 
commensurate with the hazard posed by the infectious biological agent, 
infectious material, and/or vector to be imported, and the level of 
risk given its intended use, including what elements of the plan are 
essential to prevent exposures and dramatically reduce the incidence of 
LAIs and protect the public health and environment. However, we believe 
that most, if not all, importers of etiological agents already have 
such biosafety plans based on our experience with import permit 
submissions addressing Section G (Receiving Laboratory Capabilities) of 
the permit application. The total number of applicants estimated to 
have biosafety plans from March 2011 to the present is 632 out of 644 
or 98%. CDC would be interested in comments concerning the cost and 
burden of formalizing a written biosafety plan.
    Finally, we also provided exemptions to allow importers to import 
certain material that is already approved or authorized by another 
agency or material that has been determined not to be an infectious 
biological agent. We believe this will reduce burden for clinical/
diagnostic laboratories or small business selling manufactured goods.

III. Required Regulatory Analyses Under Executive Orders 13563 and 
12866

    Executive Orders 13563 and 12866 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits, of reducing costs, of harmonizing rules, and of promoting 
flexibility. This rule has been designated a ``significant regulatory 
action'' although not economically significant, under section 3(f) of 
Executive Order 12866. Accordingly, the rule has been reviewed by the 
Office of Management and Budget.
    Based on past experience, we estimate that there will be 
approximately 2,000 applications for both import and distribution 
permit requests each year and that the average response time to 
complete the application is 20 minutes. We believe that the burden has 
been limited to requesting only essential information on the 
application, verifying information, when required, by telephone, and 
mailing information to the appropriate parties.
    With regard to the new proposed requirement to have in place 
biosafety measures, our current experience with reviewing the 
information submitted for the import permit applications addressing 
Section G (Receiving Laboratory Capabilities) (e.g., detailed 
description of any required personal protective equipment (PPE)), and 
laboratory equipment (i.e., biosafety cabinets, autoclaves) that 
ensures materials are properly handled and contained indicates that the 
vast majority of importers of etiological agents already have 
instituted such biosafety measures. In fact, based on the review of 
applications received since March 2011, we estimated that 98% (632 out 
of 644) of the applicants possess written biosafety plans and already 
follow standard biosafety practices and procedures.
    With regard to whether CDC will inspect an import facility, as 
noted above, CDC will use the following specific criteria to determine 
which entities are to be inspected--(1) facilities that request to 
perform research with imported agents that would need to be conducted 
in a BSL-3, BSL-4, ABSL-3, ABSL-4 or BSL-3 Agriculture laboratory as 
described in the BMBL (e.g., Mycobacterium tuberculosis), and (2) that 
have not been inspected by CDC's Select Agent Program.
    Since 2009, we have refined the CDC import permit database to 
include better descriptions of material being imported, the biosafety 
level of the laboratory where the work will be performed, and the type 
of work to be conducted (e.g., diagnostic, research). To estimate the 
number of facilities that we anticipate would require a biosafety 
inspection; we first identified those facilities that applied to import 
``BSL-3 agents'' for research. From that list, we deleted those 
facilities already receiving periodic biosafety from either CDC or 
APHIS inspections due to their registration with the Federal Select 
Agent Program and concluded that approximately 25 facilities would need 
to be inspected per year to verify that they have in place the 
appropriate biosafety measures that are commensurate with the risk 
posed by the infectious biological agent, infectious material, and/or 
vector, and the level of risk given its intended use. We based our 
estimate on fact that the remaining facilities would not need to be 
inspected based on our current experience with reviewing the 
information contained in the import permit applications which address 
in detail the capabilities of receiving laboratories (description of 
any required personal protective equipment and laboratory equipment 
(biosafety cabinets, autoclaves), which if used properly ensures 
materials are properly

[[Page 63895]]

handled and contained). We therefore anticipate that this requirement 
will impose only a minimal burden on importers. However, we believe 
that the addition of this requirement is important to ensure that 
current and future importing facilities have and maintain the 
appropriate biosafety measures for working safely with imported 
infectious agents by inspecting these facilities. HHS/CDC's belief in 
the importance of including a requirement that importers are subject to 
an inspection to verify the implementation of appropriate biosafety 
measures is based on our eight years of experience in the area of 
select agent regulatory oversight. While 100% of entities registered 
for the possession, use, or transfer of select agents and toxins (42 
CFR part 73) had appropriately filled out their application and had an 
adequate written biosafety plan, HHS/CDC identified, through its Select 
Agent Program inspection program, specific biosafety measure 
implementation issues in 81 of the 316 the entities inspected by HHS/
CDC since 2003. Some of the biosafety measure implementation issues 
were serious enough to require the suspension of registration or other 
restrictions on biological work at these facilities. USDA/APHIS has a 
similar experience with those Select Agent entities for which it has 
principle oversight. Thus, we have learned from inspecting entities 
registered with the HHS/CDC's Select Agent Program that the ``trust'' 
approach to accepting information received from paperwork is 
ineffective. We found that the information provided in the paperwork 
did not always match the biosafety practices that are employed by the 
facility. As such, we believe that HHS/CDC's Permitting Program should 
adopt a parallel program to verify biosafety measures.
    We also anticipate that there will be no cost to CDC to implement 
these recommended changes since we already review documents regarding 
biosafety and have a staff of fully trained and experienced biosafety 
inspectors. Finally, we believe the projected travel costs to perform 
these inspections will be at no additional cost to CDC since we plan to 
coordinate these inspections with those we are already conducting under 
the Federal Select Agent Inspection Program.
Regulatory Flexibility Act
    Under the Regulatory Flexibility Act, as amended by the Small 
Business Regulatory Enforcement Fairness Act (SBREFA) (5 U.S.C. 601 et 
seq.), agencies must consider the impact of regulations on small 
entities and analyze regulatory options that would minimize a rule's 
impacts on these entities. Alternatively, the agency head may certify 
that the proposed rule will not have a significant economic impact on a 
substantial number of small entities. As discussed above, CDC does not 
anticipate that this NPRM will have a significant economic impact on a 
substantial number of small businesses and other small entities. Of the 
entities impacted by this rule, CDC estimates that approximately 100 
applications received out of 2000 applications are from small 
businesses. U.S. Small Business Administration defines a small business 
concern as one that is independently owned and operated, is organized 
for profit, and is not dominant in its field. Depending on the 
industry, size standard eligibility is based on the average number of 
employees for the preceding twelve months or on sales volume averaged 
over a three-year period. For example, annual receipts may not exceed 
$2.5 to $21.5 million for services provided or maximum number of 
employees may range from 100 to 500 depending on the particular product 
being provided. Based on this definition, we did not consider 
universities or major pharmaceutical companies as small businesses. CDC 
would be interested in comments concerning the cost and burden of this 
proposed rule, especially from an importer that might be considered a 
small business or entity or from the private sector.

IV. Other Administrative Requirements

A. Paperwork Reduction Act of 1995

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), HHS/CDC has determined that the 
information collection and recordkeeping requirements included in this 
proposed rule are already approved by OMB under OMB control number 
0920-0199, expiration 1/31/2014. There are no new information 
collection or recordkeeping requirements in the proposed rule.
    In the past, CDC has denied applications for permits. Thus, in this 
rule, CDC proposes to provide applicants with an opportunity for a 
written appeal in the event that the CDC Director denies a request for 
a permit to import infectious biological agents, infectious material, 
or vectors under this part. Under the proposal, an applicant who wishes 
to make such an appeal would have 30 calendar days after receiving the 
denial to submit the appeal in writing to the CDC Director. The appeal 
must state the factual basis for the appeal and provide any supporting 
documentations to justify the appeal (e.g., documents that demonstrate 
the facility has the appropriate biosafety measures in place for 
working safely with requested imported material). CDC would then issue 
a written response, which would then constitute final agency action. 
CDC estimates the time to prepare and submit such a request is 4 hours. 
CDC invites comments on this process.

B. Executive Order 12988, Civil Justice Reform and Executive Order 
13132, Federalism

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform, and Executive Order 13132, Federalism. This rule: 
(1) Preempts all State and local laws and regulations that are in 
conflict with this rule; (2) has no retroactive effect; and (3) does 
not require administrative proceedings before parties may file suit in 
court challenging this rule.

C. Plain Language in Government Writing

    Pursuant to Presidential Memorandum of June 1, 1998 Plain Language 
in Government Writing (63 FR 31885), Executive Departments and Agencies 
are directed to use plain language in all proposed and final rules. CDC 
believes it has used plain language in drafting of the proposed rule 
and would welcome any comment from the public in this regard.

List of Subjects in 42 CFR Part 71

    Airports, Animals, Communicable diseases, Harbors, Imports, 
Pesticides and pests, Public health, Quarantine, Reporting and 
recordkeeping requirements.

    Dated: June 20, 2011.
Kathleen Sebelius,
Secretary.

    For the reasons stated in the preamble, the Centers for Disease 
Control and Prevention, U.S. Department of Health and Human Services, 
proposes to amend 42 CFR part 71, subpart F, as follows:

PART 71--FOREIGN QUARANTINE

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

    Authority:  42 U.S.C. 243, 248, 249, and 264-272.

    2. Revise Sec.  71.54 to read as follows:


Sec.  71.54  Import Regulations for Infectious Biological Agents, 
Infectious Material, and Vectors.

    (a) Definitions:
    Animal. Any member of the animal kingdom except a human.

[[Page 63896]]

    Diagnostic specimen. Specimens of human and animal matter 
(including tissue, blood, body discharges, fluids, excretions or 
similar material), or environmental samples.
    Genomic material. Deoxyribonucleic acid (DNA) or Ribonucleic acid 
(RNA) comprising the genome or organism's hereditary information may be 
single-stranded or double-stranded, and in a linear, circular or 
segmented configuration and may be positive sense (same polarity as 
mRNA), negative sense, or ambisense (mixture of the two).
    Infectious biological agent. A microorganism (including, but not 
limited to, bacteria (including rickettsiae), viruses, fungi, or 
protozoa) or prion, whether naturally occurring, bioengineered, or 
artificial, or a component of such microorganism or prion that is 
capable of causing communicable disease in a human.
    Infectious material. Any material which is known or suspected to 
contain a biological agent infectious to humans.
    Select agents and toxins. Biological agents and toxins that could 
pose a severe threat to public health and safety listed in 42 CFR 73.3 
and 73.4.
    Vector. Any animals (vertebrate or invertebrate) including 
arthropods or any noninfectious self-replicating system known to 
transfer or capable of transferring an infectious biological agent to a 
human.
    (b) Unless excluded pursuant to paragraph (f) of this section, a 
person may not import into the United States any infectious biological 
agent, infectious material or vector unless:
    (1) It is accompanied by a permit issued by CDC. The possession of 
a permit issued by CDC does not satisfy permitting requirements placed 
on materials by the U.S. Department of Agriculture that may pose 
hazards to agriculture or agricultural production in addition to 
hazards to human health.
    (2) The importer is in compliance with all permit requirements and 
conditions.
    (3) The importer has implemented biosafety measures commensurate 
with the hazard posed by the infectious biological agent, infectious 
material, and/or vector to be imported, and the level of risk given its 
intended use.
    (4) The importer is in compliance with all applicable laws 
concerning the packaging and shipment of infectious substances.
    (c) If noted as a condition of the issued permit, subsequent 
transfers of any infectious biological agent, infectious material or 
vector within the United States will require an additional permit 
issued by the CDC.
    (d) A permit is valid only for:
    (1) The time period and/or term indicated on the permit, and
    (2) Only for so long as the permit conditions continue to be met.
    (e) A permit can be denied, revoked or suspended if:
    (1) The biosafety measures of the permit holder are not 
commensurate with the hazard posed by the infectious biological agent, 
infectious materials, or vector, and the level of risk given its 
intended use; or,
    (2) The permit holder fails to comply with all conditions, 
restrictions and precautions specified in permit.
    (f) A permit issued under this part is not required for an item if:
    (1) It is a biological agent listed in 42 CFR Part 73 as a select 
agent and its importation has been authorized in accordance with 42 CFR 
73.16 or 9 CFR 121.16.
    (2) It is a diagnostic specimen not known by the importer to 
contain, or suspected by the importer of containing, an infectious 
biological agent and the specimen is accompanied by an importer 
certification statement confirming that the material is not known to 
contain or suspected of containing an infectious biological agent.
    (3) It consists only of nucleic acids that cannot produce 
infectious forms of any infectious biological agent and the specimen is 
accompanied by an importer certification statement confirming that the 
material is not known to contain or suspected of containing an 
infectious biological agent.
    (4) It is a product that is cleared, approved, licensed, or 
otherwise authorized under any of the following laws:
    (i) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.), or
    (ii) Section 351 of the Public Health Service Act pertaining to 
biological products (42 U.S.C. 262), or
    (iii) The Virus-Serum-Toxin Act (21 U.S.C. 151-159).
    (g) To apply for a permit, an individual must:
    (1) Submit a signed, completed CDC Form 0.753 (Application for 
Permit to Import Biological Agents or Vectors of Human Disease into the 
United States) to the CDC Import Permit Program.
    (2) Have in place biosafety measures that are commensurate with the 
hazard posed by the infectious biological agent, infectious material, 
and/or vector to be imported, and the level of risk given its intended 
use.
    (h) Issuance of a permit may be contingent upon an inspection of 
the importer's facility by the CDC to evaluate whether the importer's 
biosafety measures (e.g., physical structure and features of the 
facility, and operational and procedural safeguards) are commensurate 
with the hazard posed by the infectious biological agent, infectious 
material, and/or vector, and the level of risk given its intended use.
    (i) Denial, suspension, or revocation of a permit under this 
section may be appealed to the CDC Director. The appeal must be in 
writing, state the factual basis for the appeal, and be submitted to 
the CDC Director within 30 calendar days of the denial, suspension, or 
revocation of the permit. CDC will issue a written response to the 
appeal, which shall constitute final agency action.

[FR Doc. 2011-26656 Filed 10-13-11; 8:45 am]
BILLING CODE 4163-18-P