Federal Register / Vol. 70, No. 202 / Thursday, October 20, 2005 / Rules and Regulations 61047 

charts issued by the Federal Aviation 

Administration (FAA).’’

■ 3. Amend § 301–10.306 by revising 

the section heading to read as follows: 

§ 301–10.306 What will I be reimbursed if 

authorized to use a POV instead of a taxi 

between my residence and office to a 

common carrier terminal, or from my 

residence directly to a common carrier 

terminal on travel requiring an overnight 

stay? 

§ 301–10.310 [Amended] 

■ 4. Amend § 301–10.310 in paragraph 

(a) by removing ‘‘vehicle’’ and ‘‘27.0 

cents’’ and adding ‘‘automobile’’ and 

‘‘28.5 cents’’ in its place, respectively; 

and by removing from paragraph (b) 

‘‘10.5 cents’’ and adding ‘‘12.5 cents’’ in 

its place. 

[FR Doc. 05–20216 Filed 10–19–05; 8:45 am] 

BILLING CODE 6820–14–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

42 CFR Part 73 

Possession, Use, and Transfer of 

Select Agents and Toxins—

Reconstructed Replication Competent 

Forms of the 1918 Pandemic Influenza 

Virus Containing Any Portion of the 

Coding Regions of All Eight Gene 

Segments 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Interim final rule. 

SUMMARY: We are adding reconstructed 

replication competent forms of the 1918 

pandemic influenza virus containing 

any portion of the coding regions of all 

eight gene segments to the list of HHS 

select agents and toxins. We are taking 

this action for several reasons. First the 

pandemic influenza virus of 1918–19 

killed up to 50 million people 

worldwide, including an estimated 

675,000 deaths in the United States. 

Also, the complete coding sequence for 

the 1918 pandemic influenza A H1N1 

virus was recently identified, which 

will make it possible for those with 

knowledge of reverse genetics to 

reconstruct this virus. In addition, the 

first published study on a reconstructed 

1918 pandemic influenza virus 

demonstrated the high virulence of this 

virus in cell culture, embryonated eggs, 

and in mice relative to other human 

influenza viruses. Therefore, we have 

determined that the reconstructed 

replication competent forms of the 1918 

pandemic influenza virus containing 

any portion of the coding regions of all 

eight gene segments have the potential 

to pose a severe threat to public health 

and safety. 

DATES: The interim final rule is effective 

on October 20, 2005. Written comments 

must be submitted on or before 

December 19, 2005. 

ADDRESSES: Comments on the change to 

the list of HHS select agents and toxins 

should be marked ‘‘Comments on the 

reconstructed replication competent 

forms of the 1918 pandemic influenza 

virus containing any portion of the 

coding regions of all eight gene 

segments’’ and mailed to: Centers for 

Disease Control and Prevention, 

Division of Select Agents and Toxins, 

1600 Clifton Rd., MS E–79, Atlanta, GA 

30333. Comments may be e-mailed to: 

SAPcomments@cdc.gov. 

FOR FURTHER INFORMATION CONTACT: 

Mark Hemphill, Chief of Policy, 

Division of Select Agents and Toxins, 

Centers for Disease Control and 

Prevention, 1600 Clifton Rd., MS E–79, 

Atlanta, GA 30333. Telephone: (404) 

498–2255. 

SUPPLEMENTARY INFORMATION: The 

complete coding sequence for the 1918 

pandemic influenza A H1N1 virus has 

been recently identified (Taubenberger 

et al., 2005, Nature, vol. 437, pp. 889–

893). Scientists from the Centers for 

Disease Control and Prevention together 

with collaborators at Mount Sinai 

School of Medicine, NY, Armed Forces 

Institute of Pathology, MD, and 

Southeast Poultry Research Laboratory, 

U.S. Department of Agriculture, GA, 

reconstructed the 1918 pandemic 

influenza virus by using reverse genetics 

to study the properties associated with 

its extraordinary virulence (Tumpey et 

al., Characterization of the 

Reconstructed 1918 Spanish Influenza 

Pandemic Virus, Science 2005 310: 77–

80). With the publication of the 

complete coding sequence, it will be 

possible for other scientists with 

knowledge of reverse genetics 

technology to reconstruct the 1918 

pandemic influenza virus at other 

institutions. 

The pandemic influenza virus of 

1918–19 killed up to 50 million people 

worldwide, including an estimated 

675,000 deaths in the United States. The 

1918 pandemic influenza virus’ (H1N1) 

most striking feature was the unusually 

high death rate among healthy adults 

aged 15 to 34 years. The question of 

whether the reconstructed 1918 

pandemic influenza virus should be 

regulated as a select agent was 

considered by the Intragovernmental 

Select Agents and Toxins Technical 

Advisory Committee (ISATTAC). The 

criteria used by the ISATTAC for 

reviewing the reconstructed 1918 

pandemic influenza virus for inclusion 

on the select agent list were: degree of 

pathogenicity, communicability, ease of 

dissemination, route of exposure, 

environmental stability, ease of 

production, ability to genetically 

manipulate or alter, long-term health 

effects, acute morbidity, acute mortality, 

available treatment, status of immunity, 

vulnerability of special populations, and 

the burden or impact on the health care 

system. Based on these criteria, the 

ISATTAC determined that the 

reconstructed 1918 pandemic influenza 

virus could pose an immediate severe 

threat to public health and safety if it is 

not safely and securely maintained. 

Further, the ISATTAC noted that the 

biological and molecular properties that 

enabled the 1918 pandemic influenza 

virus to cause such widespread illness 

and death are not completely 

understood and that it is not known 

how virulent the reconstructed virus 

would be in the population today. In 

making its determination, the ISATTAC 

considered both the historical data 

regarding the original 1918 pandemic 

influenza virus and data from current in 

vitro and in vivo animal studies. The 

apparent virulence of this virus, 

together with the fact that the level of 

immunity in the general population and 

the ability of the virus to readily 

transmit among persons are unknown at 

this time, makes it prudent to 

immediately regulate this virus as a 

select agent. Although studies with this 

virus can lead to significant public 

health benefits for understanding 

pandemic influenza, improved 

diagnostics, and the development of 

more effective countermeasures, there 

are also potential risks of the misuse of 

this agent for purposes of bioterrorism 

as well as accidental release. Thus, if 

misused, the 1918 pandemic influenza 

virus may pose a biological threat to 

public health and/or national security. 

The Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 (the Bioterrorism 

Act) requires the regulation of each 

biological agent that has the potential to 

pose a severe threat to public health and 

safety. Congress recognized that a delay 

in the regulation of such biological 

agents was contrary to the public 

interest by requiring in the Bioterrorism 

Act that the initial Select Agent 

regulations be promulgated as an 

interim final rule. Therefore, the 

Secretary has determined that prior 

notice and opportunity for public 

61048 Federal Register / Vol. 70, No. 202 / Thursday, October 20, 2005 / Rules and Regulations 

comment are contrary to the public 

interest and there is good cause under 

5 U.S.C. 553 for making this rule 

effective less than 30 days after 

publication in the Federal Register. We 

will consider comments that are 

received within 60 days of publication 

of this rule in the Federal Register. 

After the comment period closes, we 

will publish another document in the 

Federal Register. The document will 

include a discussion of any comments 

we receive and any amendments that 

will be made to the rule as a result of 

the comments. In addition to seeking 

comments on the addition of this agent 

to the HHS list of select agents and 

toxins, we are also seeking comments on 

the regulation of reconstructed viruses 

that contain less than all eight gene 

segments from the 1918 pandemic 

influenza virus and if there are certain 

experiments with such constructs or 

with the fully reconstructed 1918 

pandemic influenza virus that should be 

added to the ‘‘Restricted experiments’’

provisions of the regulation. 

An entity must apply to the CDC 

Division of Select Agents and Toxins to 

possess, use, or transfer reconstructed 

replication competent forms of the 1918 

pandemic influenza virus containing 

any portion of the coding regions of all 

eight gene segments. The CDC Division 

of Select Agents and Toxins will review 

the entity’s biosafety plan to ensure that 

it provides a comprehensive risk 

assessment of the proposed research and 

adequately ensures appropriate 

biosafety measures. The CDC Division of 

Select Agents and Toxins will conduct 

a biosafety review of proposed 

experiments with the reconstructed 

1918 pandemic influenza virus on a 

case-by-case basis. The ‘‘Interim CDC–

NIH Recommendation for Raising the 

Biosafety Level for Laboratory Work 

Involving Noncontemporary Human 

Influenza Viruses’’ excerpted from the 

draft CDC/NIH Biosafety in 

Microbiological and Biomedical 

Laboratories, 5th edition will be used as 

the minimum containment for such 

experiments. However, in some cases 

supplemental biosafety measures may 

be deemed appropriate after review of 

the proposed experiments. 

The case-by-case review by CDC’s 

Division of Select Agents and Toxins 

will continue until further data are 

available that may result in changes to 

biosafety guidelines for work with the 

reconstructed 1918 pandemic influenza 

virus. Until such revised guidelines are 

available, entities should refer to the 

‘‘Interim CDC–NIH Recommendation for 

Raising the Biosafety Level for 

Laboratory Work Involving 

Noncontemporary Human Influenza 

Viruses.’’ In accordance with these 

interim guidelines, work with such 

viruses should proceed with extreme 

caution and the viruses should be 

handled, at a minimum, under highcontainment (Biosafety Level 3- 

enhanced) laboratory conditions. 

Enhancements should include the use of 

powered air purifying respirators, 

change-of-clothing and shower-out 

requirements, use of HEPA filtration for 

treatment of exhaust air, and a stringent 

medical surveillance and response plan. 

In addition to these currently published 

interim guidelines, annual vaccination 

with the currently licensed influenza 

vaccine is strongly recommended and 

antiviral prophylaxis should be 

available for individuals working with 

reconstructed replication competent 

forms of the 1918 pandemic influenza 

virus containing any portion of the 

coding regions of all eight gene 

segments. 

The addition of the 1918 pandemic 

influenza virus to the HHS select agents 

and toxins list is effective immediately. 

Entities that intend to possess, use, or 

transfer this agent will be required to 

either register in accordance with 42 

CFR part 73, or amend their current 

registration in accordance with 

§ 73.7(h). 

Paperwork Reduction Act 

In accordance with section 3507(d) of 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501 et seq.), the information 

collection or recordkeeping 

requirements included in this interim 

final rule have been approved by the 

Office of Management and Budget 

(OMB) under OMB control number 

0920–0576. 

Please send written comments on the 

new information collection contained in 

this interim final rule to Seleda 

Perryman, CDC Assistant Reports 

Clearance Officer, 1600 Clifton Road, 

MS–D74, Atlanta, GA 30333. Copies of 

this information collection may be 

obtained from Seleda Perryman, CDC 

Assistant Reports Clearance Officer, at 

(404) 639–4794 or via e-mail to 

omb@cdc.gov. 

We expect that the entities who will 

register for possession, use, or transfer 

of reconstructed replication competent 

forms of the 1918 pandemic influenza 

virus containing any portion of the 

coding regions of all eight gene 

segments will already be registered with 

the Select Agent Program. This interim 

final rule will require such an entity to 

amend its registration with the Select 

Agent Program using relevant portions 

of APHIS/CDC Form 1 (Application for 

Laboratory Registration for Possessing, 

Use, and Transfer of Select Agents and 

Toxins). Estimated time to amend this 

form is 45 minutes for one select agent. 

Additionally, any registered entity that 

wishes to transfer reconstructed 

replication competent forms of the 1918 

pandemic influenza virus containing 

any portion of the coding regions of all 

eight gene segments will be required to 

submit information using APHIS/CDC 

Form 2 (Report of Transfer of Select 

Agent and Toxins). Estimated average 

time to complete this form is 1 hour, 30 

minutes. We estimate that only one to 

five registered entities may add or 

transfer reconstructed replication 

competent forms of the 1918 pandemic 

influenza virus containing any portion 

of the coding regions of all eight gene 

segments to their registration. Therefore, 

we calculate that there is no increase in 

the number of respondents, the total 

number of responses may increase by 9, 

and the total burden hours may increase 

to 9 hours and 45 minutes. 

Executive Order 12866 and Regulatory 

Flexibility Act 

This interim final rule has been 

determined to be significant for the 

purposes of Executive Order 12866 and 

has been reviewed by the Office of 

Management and Budget. 

This emergency situation makes 

timely compliance with section 604 of 

the Regulatory Flexibility Act (5 U.S.C. 

601 et seq.) impracticable. We are 

currently assessing the potential 

economic effects of this action on small 

entities. Based on that assessment, we 

will either certify that the rule will not 

have a significant economic impact on 

a substantial number of small entities or 

publish a final regulatory flexibility 

analysis. 

Unfunded Mandates 

The Unfunded Mandates Reform Act 

at 2 U.S.C. 1532 requires that agencies 

prepare an assessment of anticipated 

costs and benefits before developing any 

rule that may result in expenditure by 

State, local, or tribal governments, in the 

aggregate, or by the private sector of 

$100 million or more in any given year. 

This interim final rule is not expected 

to result in any one-year expenditure 

that would exceed $100 million. 

Executive Order 12988 

This rule has been reviewed under 

Executive Order 12988, Civil Justice 

Reform. This rule: (1) Would preempt 

all State and local laws and regulations 

that are inconsistent with this rule; (2) 

would have no retroactive effect; and (3) 

would not require administrative 

proceedings before parties may file suit 

in court challenging this rule. 

Federal Register / Vol. 70, No. 202 / Thursday, October 20, 2005 / Rules and Regulations 61049 

Executive Order 13132 

This rule has been reviewed under 

Executive Order 13132, Federalism. 

This regulation will not have substantial 

direct effects on the States, on the 

relationship between the national 

government and the States, or on 

distribution of power and 

responsibilities among the various 

levels of government. Therefore, in 

accordance with Executive Order 13132, 

it is determined that this rule does not 

have sufficient federalism implications 

to warrant the preparation of a 

federalism summary impact statement. 

List of Subjects in 42 CFR Part 73 

Biologics, Incorporation by reference, 

Packaging and containers, Penalties, 

Reporting and Recordkeeping 

requirements, Transportation. 

Dated: October 7, 2005. 

Michael O. Leavitt, 

Secretary. 

■ For the reasons stated in the preamble, 

we are amending 42 CFR part 73 as 

follows: 

PART 73—SELECT AGENTS AND 

TOXINS 

■ 1. The authority citation for part 73 

continues to read as follows: 

Authority: 42 U.S.C. 262a; sections 201–

204, 221 and 231 of Title II of Public Law No. 

107–188, 116 Stat. 637 (42 U.S.C. 262a). 

■ 2. Amend paragraph (b) of § 73.3 by 

adding the following entry in 

alphabetical order to read as follows: 

§ 73.3 HHS select agents and toxins. 

* * * * * 

(b) * * * 

Reconstructed replication competent 

forms of the 1918 pandemic influenza 

virus containing any portion of the 

coding regions of all eight gene 

segments. 

* * * * * 

[FR Doc. 05–20946 Filed 10–17–05; 12:02 

pm] 

BILLING CODE 4160–17–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 1, 22, 24, 27 and 90 

[WT Docket No. 03–264; FCC 05–144] 

Amendment of Various Rules Affecting 

Wireless Radio Services 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: In this document, the Federal 

Communications Commission 

(‘‘Commission’’) streamlines and 

harmonizes licensing provisions in the 

wireless radio services (WRS) that were 

identified in part during the 

Commission’s 2000 and 2002 biennial 

regulatory reviews. The Commission 

concludes that streamlining and 

harmonizing these rules will clarify 

spectrum rights and obligations for 

affected licensees and support recent 

efforts to maximize the public benefits 

derived from the use of the radio 

spectrum. Among other matters, the 

Commission retains the references to 

ERP and EIRP in its rules, eliminates the 

transmitter-specific posting requirement 

of part 22 licensees, conforms the 

Emission Mask G to a modulationindependent mask that places no 

limitation on the spectral power density 

profile within the maximum authorized 

bandwidth, eliminates a rule which 

required the filing of certain outdated 

supplemental information, and 

eliminates certain transmitter output 

power limits rules. Further, in this 

document, the Commission eliminates 

many filing and data reporting 

requirements, some output power 

limits, and seeks comment on whether 

the Commission should increase other 

power limits. 

DATES: Effective December 19, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Wilbert E. Nixon, Jr. and/or B.C. ‘‘Jay’’

Jackson, Jr. of the Mobility Division, 

Wireless Telecommunications Bureau, 

at 202–418–0620 or via e-mail at 

Wilbert.Nixon@fcc.gov and/or 

Jay.Jackson@fcc.gov. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Report 

and Order portion (Report and Order) of 

the Commission’s Report and Order and 

Further Notice of Proposed Rulemaking, 

FCC 05–144, in WT Docket Nos. 03–264, 

adopted July 22, 2005, and released 

August 9, 2005. The Further Notice of 

Proposed Rulemaking portion (FNPRM) 

of the document is summarized 

elsewhere in this publication. The full 

text of the document is available for 

public inspection and copying during 

regular business hours at the FCC 

Reference Information Center, 445 12th 

St., SW., Room CY–A257, Washington, 

DC 20554. The complete text may be 

purchased from the Commission’s 

duplicating contractor: Best Copy & 

Printing, Inc., 445 12th Street, SW., 

Room CY–B402, Washington, DC, 

20554, telephone 800–378–3160, 

facsimile 202–488–5563, or via e-mail at 

fcc@bcpiweb.com. The full text may also 

be downloaded at: http://www.fcc.gov. 

Alternative formats are available to 

persons with disabilities by contacting 

Brian Millin at (202) 418–7426 or TTY 

(202) 418–7365 or at 

Brian.Millin@fcc.gov. 

Paperwork Reduction Act of 1995 

Analysis 

This document contains modified 

information collection requirements. 

The Commission, as part of its 

continuing effort to reduce paperwork 

burdens, invites the general public to 

comment on the information collection 

requirements contained in this R&O as 

required by the Paperwork Reduction 

Act of 1995, Public Law 104–13. Public 

and agency comments are due December 

19, 2005. In addition, the Commission 

notes that pursuant to the Small 

Business Paperwork Relief Act of 2002, 

Public Law 107–198, see 44 U.S.C. 

3506(c)(4), we previously sought 

specific comment on how the 

Commission might ‘‘further reduce the 

information collection burden for small 

business concerns with fewer than 25 

employees.’’

Synopsis of the Report and Order 

I. Introduction 

1. On January 7, 2004, the 

Commission released a Notice of 

Proposed Rulemaking, (NPRM) 

published at 69 FR 8132, February 23, 

2004, which commenced a proceeding 

to streamline and harmonize licensing 

provisions in the wireless radio services 

(WRS) that were identified in part 

during the Commission’s 2000 and 2002 

biennial regulatory reviews pursuant to 

section 11 of the Communications Act 

of 1934, as amended (‘‘Communications 

Act’’ or ‘‘Act’’) (47 U.S.C. 161). The 

Commission proposed various 

amendments to parts 1, 22, 24, 27, and 

90 of the rules to modify or eliminate 

provisions that treat licensees 

differently and/or have become 

outdated as a result of technological 

change, supervening changes to related 

Commission rules, and/or increased 

competition within WRS. We believe 

streamlining and harmonizing these 

rules will clarify spectrum rights and 

obligations and optimize flexibility for 

WRS licensees, fulfill our mandate 

under Section 11 of the 

Communications Act, and support 

efforts to maximize the public benefits 

derived from the use of the radio 

spectrum. Accordingly, in this Report 

and Order, we: 

• Modify our rules to classify a 

deletion of a frequency and/or 

transmitter site from a multi-site 

authorization under part 90 as a minor 

modification.