Establishment of Vaccination Clinics; User Fees for Investigational New Drug (IND) Influenza Vaccine Services and Vaccines, 3490-3493 [05-1310]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 70, Number 15 (Tuesday, January 25, 2005)]
[Rules and Regulations]
[Pages 3490-3493]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-1310]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 70

RIN 0920-AA11


Establishment of Vaccination Clinics; User Fees for 
Investigational New Drug (IND) Influenza Vaccine Services and Vaccines

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

ACTION: Interim final rule and request for comments.

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SUMMARY: We are amending 42 CFR part 70 to establish vaccination 
clinics and a user fee in connection with the administration of 
vaccination services and vaccine. On December 7, 2004, HHS Secretary 
Tommy G. Thompson announced the purchase of 1.2 million doses of 
GlaxoSmithKline (GSK) influenza vaccine, Fluarix, for distribution to 
areas most in need as determined by State public health authorities. 
The Fluarix vaccine has been approved in seventy-eight foreign 
countries, and FDA has recently reviewed extensive manufacturing and 
summary clinical information and conducted an inspection of the GSK 
manufacturing facility in Germany to determine that this vaccine, 
although not licensed in the United States, is suitable for use under 
an Investigational New Drug application (IND). The Food and Drug 
Administration (FDA) reviewed GSK's IND application as well as the 
clinical protocol and manufacturing data. CDC and CDC's Institutional 
Review Board approved the GSK flu vaccine response protocol including 
the informed consent document.
    To ensure that the vaccine is properly administered to individuals 
identified to be most at risk and facilitate compliance with IND 
requirements, CDC is establishing vaccination clinics. CDC is 
proceeding without delay because of the unprecedented nature of this 
season's influenza vaccine shortage caused by contamination problems 
with Chiron Corporation's production facility in the United Kingdom, 
which effectively cut in half the expected United States supply of 
inactivated influenza vaccine. A user fee is being established in order 
to recoup the costs associated with administering the vaccine and for 
the vaccine itself. All individuals, other than those who are enrolled 
in Medicare Part B, will be required to pay the user fee.

DATES: This interim final rule is effective upon publication.
    Written comments must be submitted on or before February 24, 2005. 
A final rule will be published after consideration of the comments.

ADDRESSES: Questions or comments concerning this interim final rule may 
be submitted to: Sheila Humphrey, Centers for Disease Control and 
Prevention, 1600 Clifton Road, NE, Mailstop D-38, Atlanta, GA 30333; 
telephone 404-498-4025. Comments may be emailed to: sph5@cdc.gov.

FOR FURTHER INFORMATION CONTACT: For information concerning program 
operations contact: Lisa Rotz, Centers for Disease Control and 
Prevention, 1600 Clifton Road, NE, Mailstop C-18, Atlanta, GA 30333; 
telephone 404-639-0153.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 361 of the Public Health Service Act (42 U.S.C. 264) 
authorizes the Secretary of HHS to make and enforce such regulations as 
in his judgment are necessary to prevent the introduction, 
transmission, or spread of communicable diseases from foreign countries 
into the United States or from one state or possession into any other 
state or possession. Influenza is a communicable disease caused by 
influenza viruses that spreads from person to person primarily through 
respiratory droplets of coughs and sneezes. Adults may be able to 
infect others 1 day before getting symptoms and up to 7 days after 
onset of illness. In light of the nature of the disease and the high 
mobility of the population, it is inevitable that influenza viruses 
will spread from individuals in one state to individuals of another 
state. The best way to prevent the transmission of influenza is for 
individuals to receive the influenza vaccine. Under the authority of 
section 361, the Secretary may establish vaccination clinics because 
vaccination with the influenza vaccine is the best way to prevent the 
transmission of influenza from one state into another.
    Title V of the Independent Offices Appropriation Act of 1952 (31 
U.S.C. 9701) (``IOAA'') provides general authority to Federal agencies 
to establish user fees through regulations. The IOAA sets parameters 
for any fee charged under its authority. Each charge shall be:
    (1) Fair; and
    (2) Based on--
    (A) The costs to the Government;
    (B) The value of the service or thing to the recipient;
    (C) Public-policy or interest served; and
    (D) Other relevant facts.
    OMB Circular A-25 (``the Circular'') establishes general policy for 
implementing user fees, including criteria for determining amounts and 
exceptions, and guidelines for implementation. According to the 
Circular, its provisions must be applied to any fees collected pursuant 
to the IOAA authority.
    The Circular states that ``[a] user charge * * * will be assessed 
against each identifiable recipient for special benefits derived from 
Federal activities beyond those received by the general public.'' The 
Circular gives three examples of when the special benefit is considered 
to accrue, including when a Government service: (a) Enables the 
beneficiary to obtain more immediate or substantial gains or values 
(which may or may not be measurable in monetary terms) than those that 
accrue to the general public (e.g., receiving a patent, insurance, or 
guarantee provision, or a license to carry on a specific activity or 
business or various kinds of public land use); or (b) provides business 
stability or contributes to public confidence in the business activity 
of the beneficiary (e.g., insuring deposits in commercial banks); or 
(c) is performed at the request of or for the convenience of the 
recipient, and is beyond the services regularly received by other 
members of the same industry or group or by the general public (e.g., 
receiving a passport, visa, airman's certificate, or a Customs 
inspection after regular duty hours).
    The Circular sets forth guidelines for determining the amount of 
user charges to assess. When the Government is acting in its sovereign 
capacity, user charges should be sufficient to cover the full cost to 
the Federal Government of providing the service, resource, or good.
    The Circular sets forth criteria for determining full cost. ``Full 
cost includes all direct and indirect costs to any part of the Federal 
Government of providing a good, resource, or service.'' Examples of 
these types of costs include, but are not limited to, direct and 
indirect personnel costs, including salaries and fringe benefits; 
physical overhead, consulting, and other indirect costs, including 
material and supply costs, utilities, insurance, travel, and rents; 
management and supervisory costs; and the costs of enforcement, 
collection, research, establishment of standards, and regulation. Full 
costs are

[[Page 3491]]

determined based on the best available records of the agency.
    Agencies are responsible for the initiation and adoption of user 
charge schedules consistent with the guidance listed in the Circular. 
In doing so, agencies should identify the services and activities 
covered by the Circular; determine the extent of the special benefits 
provided; and apply the principles set forth in the Circular in 
determining full cost or market cost as appropriate.

II. Introduction

    Influenza, commonly known as ``the flu,'' is a contagious 
respiratory illness caused by a virus. In the United States, on average 
per year, 5% to 20% of the population gets the flu; more than 200,000 
people are hospitalized from flu complications; and approximately 
36,000 people die from flu. The best way to reduce the risk of getting 
the flu is to get a flu vaccine each fall.
    On October 5, 2004, Chiron Corporation notified HHS, through the 
CDC, that none of its influenza vaccine would be available for 
distribution in the United States because of contamination problems 
with its facility in the United Kingdom. As a result, the expected 
supply of inactivated influenza vaccine (flu shot) was effectively cut 
in half. Increased production by MedImmune and Aventis alleviated some 
of the shortfall, but vaccine supplies were still cut by about 40% from 
expected levels. While the current influenza season has been mild so 
far, each influenza season is unpredictable with cases typically 
peaking between December and March. Therefore, the full severity of the 
2004-2005 influenza season is not known.
    In response to the vaccine shortage, CDC has announced priority 
groups that are more restricted than usual for vaccination with 
inactivated influenza vaccine for the 2004-2005 flu season. The 
priority groups, as they are called, number nearly 100 million persons 
and include the following persons:
     All children aged 6-23 months;
     Adults aged 65 years and older;
     Persons aged 2-64 years with underlying chronic medical 
conditions;
     Residents of nursing homes and long-term care facilities;
     Children aged 6 months-18 years on chronic aspirin 
therapy;
     All women who will be pregnant during the influenza 
season;
     Healthcare workers involved in direct patient care; and
     Household contacts of infants less than 6 months.
    Effective January 3, 2005, in locations where state and local 
health authorities judge the vaccine supply to be adequate to meet the 
demand from groups on the restricted priority list, the priority groups 
for inactivated influenza vaccine may be expanded to include adults 
aged 50-64 years and out-of-home caregivers and household contacts of 
persons in high-risk groups. As demand for the vaccine evolves, CDC may 
further revise its recommended categories of individuals who should 
receive influenza vaccine, including the investigational vaccine.
    On December 7, 2004, HHS Secretary Tommy G. Thompson announced the 
purchase of 1.2 million doses of GSK influenza vaccine, Fluarix, for 
distribution to areas most in need as determined by State public health 
authorities. Fluarix has not been licensed for use in the United States 
and will be administered under an IND. The Fluarix vaccine purchased by 
HHS has been approved in Germany and in about seventy-eight other 
countries worldwide, but is considered an investigational vaccine 
because it is not currently licensed by FDA.
    Under an IND, patients who are offered the Fluarix vaccine must 
sign an informed consent form that provides important information on 
the risks and benefits, including potential adverse effects associated 
with the vaccine. The sponsor of this IND, GSK, is required to monitor 
the use of the investigational product, maintain adequate records, 
control the supply of the product, provide periodic reports to FDA 
regarding safety and other issues, and make sure informed consent is 
obtained from individuals before they receive the vaccine. FDA 
regulations in parts 312, 50, and 56 of Title 21 of the Code of Federal 
Regulations help ensure FDA's ability to monitor clinical 
investigations. These regulations specify the clinical investigators' 
responsibilities while administering the investigational vaccine, as 
well as the responsibilities of the sponsor, or a contract research 
organization to which the sponsor has delegated responsibilities. Those 
regulations also specify FDA's role and authority during and after the 
administration phase, such as its role in reviewing VAERS reports. To 
ensure that the vaccine is properly administered to individuals 
identified to be most at risk and facilitate compliance with IND 
requirements, CDC is establishing influenza vaccination clinics. A user 
fee is being established in order to recoup the costs associated with 
administering the vaccine and for the vaccine itself. Under an IND, 
commercialization of an investigational product in a clinical trial is 
not permitted without the prior written approval of FDA, and then the 
sponsor may only charge a price necessary to recover the costs of 
manufacture, research, development, and handling of the investigational 
drug. 21 CFR 312.7. GSK has sought and been granted a waiver of this 
IND provision in order to provide Fluarix on an expedited basis. 21 CFR 
312.10. In addition, FDA has granted a waiver to GSK and CDC under 21 
CFR 312.10 to authorize the user fee charge for costs associated with 
administration of the Fluarix vaccine. All persons, other than those 
who are enrolled in Medicare Part B, will be required to pay the user 
fee. Under Title 18 of the Social Security Act, the Center for Medicare 
and Medicaid Services will reimburse CDC's contractor for the costs 
associated with administration of vaccine provided to individuals 
enrolled in Medicare Part B. For this reason, the user fee will not be 
applied to such individuals.

III. Services and Activities Covered by User Fee

    The user fee will cover the costs of the purchase of the Fluarix 
vaccine in addition to costs associated with administering the flu 
vaccine. The following is a list of services and activities that are 
covered by the user fee. Costs may be included in the user fee other 
than those listed here:
     Executing and administering the IND Influenza Vaccine 
Program according to the Protocol and Investigator's Handbook;
     Providing information to the participants about the 
program;
     Collecting information designated on the eligibility 
forms;
     Obtaining informed consent and collecting signed consent 
forms from eligible participants;
     Providing and administering vaccine to participants per 
protocol procedures;
     Tracking vaccine storage and accountability;
     Safely keeping and storing all funds collected via cash or 
check from IND participants;
     Ensuring the ability and capacity of the sites to 
correctly file and source IND documents and store them securely;
     Key punching program data at each vaccination site within 
two days of vaccinating participant(s) via CDC's web-accessed portal;
     Identifying any deviations from the program that might 
occur and documenting them accordingly;
     Providing all necessary data forms such as enrollment 
packets, which will also include an informed consent form and a Vaccine 
Adverse Event Reporting Systems (VAERS) form, to participants;

[[Page 3492]]

     Keeping a roster of personnel who carried out activities 
related to the IND including: (1) Obtained informed consent, (2) 
confirmed eligibility and information on eligibility form, (3) 
administered vaccine, and (4) were responsible for storage and 
maintenance of vaccine at each clinic on the days of vaccination;
     Performing all provided services in accordance with 
industry standards, including sterile collection, handling and 
processing procedures, and hazardous medical waste guidelines; and
     Recording in the medical records any adverse reactions to 
vaccines in accordance with the VAERS protocol and to the FDA as 
required by law.

IV. Special Benefit Provided

    Individuals vaccinated for influenza obtain a health benefit 
compared to unvaccinated individuals. Influenza is a serious disease. 
In an average year, influenza infection is associated with 36,000 
deaths (mostly among those aged 65 years or older) and more than 
200,000 hospitalizations in the United States. The ``flu season'' in 
the United States is usually from November through April each year. 
During this time, flu viruses are circulating in the population. An 
annual flu vaccine is the best way to reduce the chances that an 
individual will get the flu. Individuals who get vaccinated after 
December can still benefit, if flu is present then or later in the 
community. The vaccine should continue to be offered to unvaccinated 
people throughout the flu season as long as vaccine is still available. 
Once vaccinated, the human body makes protective antibodies in about 
two weeks.
    Individuals vaccinated with the Fluarix vaccine under CDC auspices 
obtain a special benefit not accruing to individuals in the general 
public who are not vaccinated. To assess the use of influenza vaccine 
this season, CDC temporarily added new questions to the Behavioral Risk 
Factor Surveillance System (BRFSS) beginning November 1, 2004. BRFSS is 
a monthly, ongoing telephone survey conducted by state health 
departments with assistance from CDC. Results of interviews conducted 
December 1-11, 2004 to assess vaccination during September 1-November 
30, 2004 were published in the December 17 issue of CDC's Morbidity and 
Mortality Weekly Reports (MMWR).
    Among adults in all vaccination priority groups, 34.8% reported 
receiving an influenza vaccination since September 1, 2004, compared 
with 4.4% of adults aged 18-64 years who were not in a priority group. 
Among all adults, coverage was highest among persons aged >=65 at 
51.1%, followed by 34.2% of health-care workers with patient contact, 
and 19.3% of high-risk adults aged 18-64 years. The percentage of 
persons reporting that they obtained an influenza vaccination September 
1-November 30, 2004 is lower in each of these groups than the 
percentage who said they obtained a vaccination during the last 
influenza season (September 1, 2003-March 30, 2004).
    Among adults in a vaccination priority group who have not received 
vaccine so far this season, 23.3% reported that they tried to obtain 
the vaccine and could not. Among persons aged 65 years and over, 32.5% 
reported that they tried to get the vaccine and could not. Among 
respondents with an unvaccinated child aged 6-23 months, 8.4% tried but 
could not obtain vaccination. For respondents with an unvaccinated 
eligible child aged 2-17 years, 14.4% reported that they tried but 
could not obtain vaccination. By establishing its own vaccination 
clinics, CDC will be able to help assure an adequate supply of the 
vaccine for individuals who choose to receive the Fluarix vaccine.

V. Analysis of User Fee Charge (Cost to the Government)

    The cost to the Government of the user fee was determined in two 
parts. The first was for the cost of purchase of Fluarix by CDC at 
$7.00 per dose. The second part is for administration of the vaccine. 
CDC has entered into a contract with a Contract Research Organization 
to administer this vaccine. The costs associated with administration of 
the vaccine (see services and activities in section III above) were 
determined to be $18.00 per dose. The total cost to the Government and 
therefore the total user fee is determined to be $25.00 per dose.

VI. Emergency Action

    We are proceeding without notice and comment rulemaking because we 
need to respond immediately to the unprecedented influenza vaccine 
shortage. Under the provisions of the Administrative Procedure Act at 5 
U.S.C. 553(b)(3)(B) and 553(d)(3), we find good cause that prior notice 
and comment on this rule and a 30-day delay in effective date is 
impracticable and contrary to the public interest.
    After November and December, many persons who should or want to 
receive influenza vaccine remain unvaccinated. To improve vaccine 
coverage, influenza vaccine should continue to be offered throughout 
the influenza season as long as vaccine supplies are available, 
including after influenza activity has been documented in the 
community. In the United States, seasonal influenza activity can begin 
to increase as early as October or November, but influenza activity has 
not reached peak levels in the majority of recent seasons until late 
December--early March, with seasons typically peaking most often in 
February. Therefore, although the timing of influenza activity can vary 
by region, vaccine administered after December on a national basis is 
likely to be beneficial in the majority of influenza seasons. Adults 
develop peak antibody protection against influenza infection 2 weeks 
after vaccination.
    We expect influenza activity to continue and to increase over the 
next few to several weeks based on current surveillance data, 
especially the finding that only about 3.1% of respiratory specimens 
submitted to the World Health Organization (WHO) and the National 
Respiratory and Enteric Virus Surveillance System (NREVSS) for 
influenza testing are positive for influenza. Normally, at the peak of 
the influenza season over 20% of specimens submitted for influenza 
testing will test positive for influenza. However, we cannot predict 
when the season will peak or the duration of the season.
    Accordingly, given the likelihood (based on historical evidence) 
that influenza cases may peak in February, obtaining prior notice and 
comment is impracticable and contrary to the public interest because it 
would delay implementation of this rule to the extent that the vaccine 
may not be administered in time for it to be effective.

VII. Regulatory Analyses

Economic Impact (Executive Order 12866)

    We have examined the impacts of the interim final rule under 
Executive Order 12866, which 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). We have 
determined that the rule is consistent with the principles set forth in 
the Executive Order, and that while it is a significant regulatory 
action it is not an ``economically significant regulatory action'' 
within the meaning of Executive Order 12866.

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Regulatory Flexibility Act

    We have examined the impacts of the interim final rule under the 
Regulatory Flexibility Act (5 U.S.C. 601-612). Unless we certify that 
the rule is not expected to have a significant economic impact on a 
substantial number of small entities, the Regulatory Flexibility Act, 
as amended by the Small Business Regulatory Enforcement Fairness Act 
(SBREFA), requires agencies to analyze regulatory options that would 
minimize any significant economic impact of a rule on small entities. 
The Regulatory Flexibility Analysis concludes that the rule is not 
expected to have a significant impact on a substantial number of small 
entities.

Small Business Regulatory Enforcement Fairness Act of 1996

    This regulatory action is not a major rule as defined by Sec. 804 
of the Small Business Regulatory Enforcement Fairness Act of 1996. This 
interim final rule will not result in an annual effect on the economy 
of $100,000,000 or more; a major increase in cost or prices; or 
significant adverse effects on competition, employment, investment, 
productivity, innovation, or on the ability of United States-based 
companies to compete with foreign-based companies in domestic and 
export markets.

Paperwork Reduction Act

    The interim final rule does not require any information 
collections. Therefore, we have not conducted a Paperwork Reduction Act 
analysis.

National Environmental Policy Act (NEPA)

    The interim final rule is excluded from NEPA's environmental review 
requirements, pursuant to 48 FR 9374-02 (National Environmental Policy 
Act (NEPA), Review of Program Actions), based on the determination that 
it will not normally significantly affect the human environment.

Civil Justice (Executive Order 12988)

    This interim final rule is in compliance with Executive Order 
12988.

List of Subjects in 42 CFR Part 70

    Communicable diseases, Public health, Quarantine, Reporting and 
recordkeeping requirements, Travel restrictions, User fees, 
Vaccination.


0
For the reasons set forth in the preamble, amend part 70 of title 42 of 
the Code of Federal Regulations as follows:

PART 70--INTERSTATE QUARANTINE

0
1. The authority citation for part 70 is revised to read as follows:

    Authority: Secs. 215 and 311 of the Public Health Service (PHS) 
Act, as amended (42 U.S.C. 216, 243); section 361-369, PHS Act, as 
amended (42 U.S.C. 264-272); 31 U.S.C. 9701.


0
2. Add Sec.  70.9 to read as follows:


Sec.  70.9  Vaccination clinics.

    (a) The Director may establish vaccination clinics, through 
contract or otherwise, authorized to administer vaccines and/or other 
prophylaxis.
    (b) A vaccination fee may be charged for individuals not enrolled 
in Medicare Part B to cover costs associated with administration of the 
vaccine and/or other prophylaxis. Such fee is to be collected at the 
time that the vaccine is administered. The vaccination fee, if imposed, 
is shown in the following table:

------------------------------------------------------------------------
                                                Effective
                   Vaccine                        dates        Amount
------------------------------------------------------------------------
Fluarix.....................................   \1\1/25/05   \2\ $25.00
------------------------------------------------------------------------
\1\ Continuing for one year.
\2\ $7.00 for the vaccine and $18.00 for administration.


    Dated: January 12, 2005.
Tommy G. Thompson,
Secretary.
[FR Doc. 05-1310 Filed 1-19-05; 1:30 pm]
BILLING CODE 4160-17-P