[Federal Register: January 25, 2005 (Volume 70, Number 15)]
[Rules and Regulations]
[Page 3490-3493]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25ja05-5]
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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.
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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:
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Effective
Vaccine dates Amount
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Fluarix..................................... \1\1/25/05 \2\ $25.00
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\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]
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