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Planning Guide for Vaccinating Pediatric Patients Against 2009 H1N1 Influenza in Primary Healthcare Settings

This website is archived for historical purposes and is no longer being maintained or updated. For updated information on the current flu season, see the CDC Seasonal Flu website.

November 3, 2009, 4:00 PM ET

Purpose of this document: To provide guidance for planning and conducting 2009 H1N1 influenza vaccination of pediatric patients in primary healthcare settings including:

  • Provider offices (pediatricians, family practice physicians, primary care providers, obstetricians/gynecologists)
  • Federally Qualified Health Centers and “look-alikes”, Community health clinics, Urgent Care clinics, Retail-based clinics

This document is a companion document to the Healthcare Providers and Facilities - Decision Tree for 2009 H1N1 Vaccination.

Target Audience: Physicians, nurses, office managers, infection control coordinators, and anyone responsible for carrying out 2009 H1N1 influenza vaccination in pediatric healthcare settings. This document can be adapted for use by providers and healthcare facilities that serve adult patients. This document can also be used by state and local public health planners to assist with vaccine distribution and coordination of related community mitigation.

Background

The first available doses of the 2009 H1N1 influenza vaccine are anticipated by early to mid-October. The Advisory Committee on Immunization Practices (ACIP) has recommended that the following target groups (no ordering among groups) first receive the 2009 H1N1 vaccine when it becomes available: people ages 6 months to 24 years; pregnant women, people 25-64 years who have certain chronic medical conditions, such as heart or lung disease, diabetes, weakened immune systems, blood disorders, neurologic or neuromuscular disease, and other illnesses; parents and caregivers of children less than 6 months of age; and healthcare workers and emergency medical services personnel.

The target age groups include pediatric patients 6 months through 18 years of age, a group that is also recommended to receive the annual seasonal influenza vaccine. Children, especially those younger than 5 years of age and those who have high risk medical conditions are at increased risk of influenza-related complications. For a more detailed description of children at highest risk, read Children with Developmental Disabilities and Chronic Medical Conditions.

This year there will be a fully-implemented recommendation for seasonal influenza vaccination for all children 6 months through 18 years old.  In previous years, seasonal influenza vaccination was recommended only for certain age and medical groups.  CDC estimates that in implementing this recommendation, about 30 million additional children will need to receive seasonal influenza immunizations this year. As state and local planners determine the 2009 H1N1 vaccine planning actions needed in their community, they may or may not consider primary healthcare providers as a key partner in an overall tiered approach.

Most communities are planning on several approaches to vaccinating children including vaccination in primary healthcare settings, vaccination at clinics organized by public health in collaboration with other partners, and potentially at school-located vaccination clinics. The latter approach is especially important for school-age children who infrequently visit their primary healthcare provider or for those children whose school is their primary place of care, or “medical home.”

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There are several potential benefits to vaccinating children in primary healthcare settings

  • Vaccinating in primary healthcare settings allows children to remain in the care of their medical home – this ensures comprehensive care and easy access and tracking of children’s medical records.
  • Primary care physicians have established relationships with families of children requiring vaccination – parents are used to seeking care and advice from their child’s physician and trust these individuals to treat their children.
  • Younger children and children with high-risk conditions regularly visit primary healthcare settings for care – this gives an opportunity to combine vaccination with health supervision visits, acute, trauma and chronic visits (e.g., asthma or diabetes visits), and to educate others who may accompany a child to their appointment.   
  • Primary healthcare providers are familiar with monitoring, responding to, and reporting any adverse events associated with routine vaccinations.
  • Primary healthcare settings are familiar with the billing and recording procedures that accompany typical vaccine distribution. Many pediatric primary healthcare settings have access to statewide immunization information systems (IIS) in those states where they are available, which will allow for better tracking, recall, and reminder of immunizations against both seasonal influenza and 2009 H1N1 influenza.
  • Primary healthcare settings may be able to vaccinate children ages 6 months to 4 years that might be missed by school-located vaccine clinics because they do not attend school.

There are also several potential challenges with providing 2009 H1N1 influenza vaccines in primary healthcare settings or “medical home”

  • Providing 2009 H1N1 influenza vaccine and seasonal influenza vaccine could result in a surge in visits that may be overwhelming to staff. Providing 2009 H1N1 Influenza vaccine may not be a feasible option for all primary healthcare facilities depending on their size, available resources, and capabilities.
  • Without prior planning, vaccinating in primary healthcare offices could mix ill (or exposed) children with well children waiting to be vaccinated.
  • Some primary healthcare entities may not have the clinical space needed or plans in place to accommodate 2009 H1N1 influenza vaccination.
  • Some providers may not have the cold-storage capacity to appropriately refrigerate 2009 H1N1 Influenza vaccine in addition to seasonal influenza vaccine. Purchasing additional refrigerators for storage can be costly.
  • Providing 2009 H1N1 influenza vaccine could present a considerable financial burden to clinicians. The federal government is providing vaccine and supplies to providers at no charge and providers are allowed to charge an administration fee. However, reimbursement for vaccine administration from private insurers, Medicaid or Medicare may not cover all associated costs (e.g., overtime expenses for staff).
  • In some areas, healthcare providers are not normally part of community emergency planning activities. They may not be aware of public health’s role in the 2009 H1N1 response and may not know how to engage with public health and other emergency responders.

Instructions

This planning guide contains two short checklists. These include:

  1. Initial Planning Checklist: The purpose of this checklist is to outline items your office should consider when deciding whether your facility is able to provide the 2009 H1N1 influenza vaccine.
  2. Moving Forward Checklist: The purpose of this checklist is to help your facility develop a plan to provide 2009 H1N1 influenza vaccine.

Each checklist presents basic questions and information in a step-by-step format.  Resource links are provided at each step, should you need additional information regarding a specific topic.  

NOTE:  Throughout the planning guide, you will see some topic areas are mentioned more than once.  These topics are important to consider BEFORE and DURING planning.

Before you Begin

State and local public health planners are working to determine the best strategies to distribute 2009 H1N1 influenza vaccine in their jurisdictions to ensure that it is easily accessible to persons recommended for vaccination.

  • Check the CDC H1N1 website or your state/local health department’s website to find out your state and local public health agencies’ plans for 2009 H1N1 influenza vaccinations in your community. Check to see:   
  • If 2009 H1N1 influenza vaccine will be administered in both public and private sector settings 
  • If the private setting plan includes 2009 H1N1 influenza vaccination in healthcare provider offices
  • If mass vaccination clinics will be used, does this include school-located vaccinations? Which groups, if any, will be targeted for vaccination at these clinics?

If your state and local public health planners DO NOT have plans to incorporate primary healthcare providers, stop here and consider how you may help communicate your community plans to your patients.

If your state and local public health planners DO have plans to include primary healthcare providers in 2009 H1N1 influenza vaccination, please proceed to the Initial Planning Checklist.

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Additional Information and Resources:

Each state or jurisdiction will have its own provider agreement. See the State/Jurisdictional Contact Information for Providers Wanting to Give 2009 H1N1 influenza vaccine.

If you do not find a contact or link to your state’s provider agreement through the above link, go to your state department of health website.

2009 H1N1 vaccine questions and answers are available.

For more information on school-located vaccination clinics, please see School-Located Vaccination Planning Materials and Templates

Initial Planning Checklist

  • Read the “Before you Begin” section to identify your state’s distribution plans regarding primary healthcare providers.
  • If your state’s distribution plan includes primary healthcare providers, complete the Initial Planning Checklist FIRST to determine whether or not you should vaccinate.
Step 1: Learn more about your potential role as a provider of the 2009 H1N1 influenza vaccine.

If your state/local health jurisdiction is planning to include primary healthcare providers in the 2009 H1N1 influenza vaccination campaign, consider contacting your local public health department to formulate a plan on how to integrate into the community plan for vaccine distribution.

Familiarize yourself with the requirements in your state’s provider agreement.

Step 2:  Other Providers

Talk to other providers (hospitals and offices/clinics) to see what 2009 H1N1 influenza vaccination services they will be offering.

Step 3:  Complete a Needs Assessment

Write down a list of who might need to receive a 2009 H1N1 influenza vaccine in your practice or facility.

For example:

You may want to also estimate the proportion of your patients in target groups who would prefer to get 2009 H1N1 influenza vaccine in your office (instead of other settings).

You may need to check where your healthcare staff plan to get 2009 H1N1 influenza vaccine. Refer to the ACIP definition for healthcare personnel.

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Step 4:  How do we finance this and what is required to recoup costs?

The 2009 H1N1 influenza vaccine will be distributed to providers free of charge and will include needles, syringes, sharps containers, alcohol swabs and influenza vaccination record cards.  Providers will be able to bill insurers/third-party payors or charge the patient a fee for vaccine administration. If a patient is charged an out-of-pocket fee (e.g., uninsured patient), the fee cannot exceed the regional Medicare vaccine administration rate.

  • Determine if the health insurers you contract with will cover administration of 2009 H1N1 influenza vaccine and what the reimbursement will be.
  • Determine what your state’s Medicare and Medicaid reimbursement rates will be.
  • Estimate potential costs for additional staffing and equipment/supplies associated with administering the 2009 H1N1 influenza vaccine.

Additional Information and Resources:

Refer to the 2009 Vaccine administration rates paid by Medicare.

If 2009 H1N1 influenza vaccine administration is not a covered benefit, consider using a waiver or advanced beneficiary notice (ABN) as part of the provider’s financial policy. A waiver is a statement that the responsible party (patient/parent/legal guardian) signs accepting financial responsibility for a requested medical service which may or may not be covered by health insurance.

To assist in determining the associated costs of vaccine storage as well as the costs related to immunization administration, see the AAP Business Case for Pricing Vaccines and Immunization Administration.

Additional information on billing for the H1N1 influenza vaccine is provided in the Moving Forward Checklist.

Step 5: What are our major staffing needs?
  • Make a determination of what kind of staffing you may need to vaccinate your patients against 2009 H1N1 influenza.

Additional Information and Resources:

Refer to the CDC Guidelines for Large-Scale Influenza Vaccination Clinic Planning

Consider that you may need to have staff who perform the following functions in excess of normal business:

  • Triage or initial intake (screening) – to determine which patients fall into the target groups for 2009 H1N1 influenza vaccination and those which do not (should supply be limited)
  • Managing room/space and patient flow – this may include runners to keep vaccinators and assistants supplied
  • Vaccinating patients and monitoring for adverse reactions
  • Billing/Administrative paperwork
  • Immunization Registry data entry or other methods for reporting doses administered Determine state requirements and if these requirements involve work in addition to what your practice routinely does. This role could be filled by volunteers (consider contacting your local health department for assistance if you cannot find volunteers. Some health departments are offering to assist providers with data entry into immunization registries).

Depending on the size of your practice and the demand for vaccine from patients, your clinic may need to scale down or modify the High-Volume Influenza Vaccination Clinic diagram provided in the above guidance.

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Step 6:  Legal Considerations

Familiarize yourself with liability and legal protections for providers and additional staff giving 2009 H1N1 influenza vaccines under the Public Readiness and Emergency Preparedness (PREP) Declaration Act.

Consider the possible legal issues associated with different types of staff you may bring in to assist (e.g., students, volunteers, retirees).

Additional Information and Resources:

Ask the state chapters of your medical specialty societies and/or your state medical society for guidance on laws regarding qualifications for legally giving vaccines and/or if there are training programs for those wishing to help vaccinate.

For more information on Public Readiness and Emergency Preparedness (PREP) Act Declarations.

Step 7:  What is my storage capacity?

Determine how much space you have to store the 2009 H1N1 influenza vaccine in addition to your current vaccine inventory. 2009 H1N1 influenza vaccine will need to be maintained at 2-8°C (35°F and 46°F) and will be available in lots of 100 doses. The majority of vaccine will be in multi-dose vials, the remainder in single dose syringes or nasal sprayers.

Additional Information and Resources:

Contact your emergency management agency, public health department, and/or local hospital for the possibility of shared community storage.
For more information on vaccine storage and handling or Checklist for Safe Vaccine Handling and Storage

Additional strategies for storage of 2009 H1N1 influenza vaccine are provided in the Moving Forward Checklist.

-YOU HAVE REACHED THE END OF THE INITIAL PLANNING CHECKLIST-

  • Make a decision about whether to continue forward with your 2009 H1N1 influenza vaccine planning.
  • If you decide to vaccinate, proceed to the Moving Forward Checklist.
  • If you are unable to provide 2009 H1N1 influenza vaccine, familiarize your practice with the community vaccine distribution plan and develop appropriate messaging to give to parents that call or show up in the office wanting a vaccine. Also, consider volunteering in school-based or other large- scale community vaccine distribution clinics.

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Moving Forward Checklist

-COMPLETE THIS CHECKLIST ONLY IF YOU DECIDE TO PROVIDE 2009 H1N1 INFLUENZA VACCINE-
Placing your orders

Estimate the number of vaccine doses you may need based on the amount of seasonal flu vaccines you have administered in previous years. Refer back to your needs assessment list above.

Take necessary steps to order vaccine supply as defined by your public health agency.  Please be aware that the process for allocating vaccine across providers will vary from one state/local jurisdiction to another. Public health will inform providers of the vaccine process and of the information they will need in order to allocate the vaccine. It is anticipated that as vaccine becomes more plentiful providers will be able to place orders directly with public health.

Additional Information and Resources:

Consult state and local public health officials to obtain a copy of your state’s provider agreement form/survey:

Read more information on the plans for distribution of the 2009 H1N1 influenza vaccine

Storage and capacity to store

Inventory your current stock of vaccines. Then formulate a vaccine-handling and storage plan based on the space requirements of adding 2009 H1N1 influenza vaccines.

Determine your state/local jurisdiction’s plan for vaccine distribution including any minimum quantity requirements.

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Additional Information and Resources:

2009 H1N1 influenza vaccine will need to be maintained at 2-8°C (35°F - 46°F).  Inactivated vaccine will be available in single dose prefilled syringes and multi-dose vials. Live attenuated intranasal vaccine (LAIV) will also be available.
Talk with your emergency manager or hospital to identify extra refrigeration capacity if necessary:

  • Portable refrigerators with thermometers (Note- Dormitory-style refrigerators are not adequate for long-term or permanent storage of biological products because they do not maintain appropriate temperatures)
  • Sharing refrigerator space with others
  • Storing at one central location (hospital)

Public health agencies will provide information on frequency of shipments to your practice in increments dependent on your capacity (e.g., weekly shipments to avoid overrunning refrigeration space).

For more information on vaccine storage and handling, please refer to the following links:

Billing / Reimbursement

The CPT Category I code established for reporting the 2009 H1N1 vaccine:

  • 90663 (Influenza virus vaccine, pandemic formulation, H1N1)

For administration of 2009 H1N1 vaccine, report the following code:

  • 90470 (H1N1 immunization administration (intramuscular, intranasal), including counseling when performed)

The CMS’s HCPCS Level II codes for the 2009 H1N1 vaccine are as follows:

  • G9141 – Influenza A (H1N1) immunization administration (includes the physician counseling the patient/family)
  • G9142 – Influenza A (H1N1) vaccine, any route of administration
  • Providers may elect to submit codes G9141 and G9142 together. However, since CMS will not provide payment for the 2009 H1N1 vaccine itself, only the vaccine administration code is required for payment.
It is important to check with your payers to determine coverage and eligibility. If the 2009 H1N1 influenza vaccine is a covered benefit and you are contracted with a patient's health insurance plan, then you are required to bill that plan for the service.

Additional Information and Resources:

For more information on Billing Medicare for the Administration of the Influenza A (H1N1) Virus Vaccine

For more information on financing administration of 2009 H1N1 vaccine.

Carrier claims payment platforms vary and there may be differences in how the system processes claims for vaccines with no charge. For example, HCPCS Level II modifier SL (state supplied vaccine) may be appended to the 90663 vaccine code to indicate a state supplied vaccine was provided. This would cue the carrier claims system that the vaccine was provided at no charge and the fee for the 90663 would be $0.00.

Some carriers have reported their systems cannot accept a $0.00 charge. Providers should follow instructions provided by the health plans with whom they contract related to billing for 2009 H1N1 vaccine administration

Human Resources (HR)/Staff planning

Talk to your Human Resources (HR) person about overtime policies and other potential challenges that might arise. 

Develop policies (e.g., teleworking, paid leave, etc.) for staff that become ill due to seasonal or 2009 H1N1influenza and for staff that decline one or both of these vaccinations.

Review or create appropriate HR policies.

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Additional Information and Resources:

For additional information to assist with planning for your employees:
CDC Guidance for Businesses and Employers To Plan and Respond to the 2009–2010 Influenza Season or Business Planning 

 A. Develop your plan and get feedback

Decide/discuss when vaccines will be given in your office (e.g., regular hours, special shifts, weekend clinics).

It will be critical to obtain staff buy-in to any altered scheduling.

Additional Information and Resources:

Options to consider:

  • Extend hours to hold early morning and evening vaccine clinics.
  • Consider weekend clinics.
  • Partner with others (particularly for small practice settings) to share the burden of extended staff hours.
  • Vaccinate all children that enter the office – including those that accompany siblings on well-child, acute, or chronic visits.
  • Temporarily suspend well-child visits and other non-essential activities to accommodate surge of children needing vaccination.
  • Vaccinate by appointment only (except in cases where a child accompanies another to an appointment) to allow staff to pull needed medical records the evening before and decrease day-of-visit paperwork.
  • Educate staff on the importance of their involvement in the community 2009 H1N1 influenza response. Consider providing incentives to staff asked to work overtime (e.g., appreciation party or dinners if cash incentives are not feasible).
  • Schedule weekend or after-hours clinics advertising “family-centered care” at which an entire family can receive vaccines if they fit recommended guidelines. Persons recommended for vaccination should be clearly defined and advertised.

For more information,

Patients that are in the initial groups targeted for vaccination by ACIP guidance

 B. Healthcare Setting

Discuss how you might efficiently set up your clinical space to administer the vaccine. Consider ways to handle patient flow to avoid mixing well and sick persons. Assign appropriate staff to coordinate and monitor the set up of vaccination areas in your clinical space.Consider additional options for separating well-children (who may be receiving vaccines  or having a “well-child” visit) from children who may be ill or exposed:

  • Alter scheduling – provide vaccines only on certain days, only in the evenings, or during Saturday clinics. 
  • Vaccinate in non-traditional settings separate from sick children (office parking lot, in personal vehicles).
  • Use phone triage for directing patient flow – have one option for regular and informational calls, and another for those who may have severe cases of illness. A sample message for Pediatrician clinics caring for children is available. Also consider, developing a script for triage to ensure high-risk patients come in for vaccination (e.g., Are you pregnant? Do you have children in your household who are younger than 6 months old?).
  • Establish separate entrances and waiting areas for well children and ill/exposed children.

Consider special infection control measures required for pediatric patients such as replacing waiting room toys and books with videos or asking parents to bring their own toys from home to help occupy their children during potentially long wait times.

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Additional Information and Resources:

Review current CDC recommendations for Infection Control for Patients in Healthcare Settings.

(Please note that guidelines are updated as additional information on transmission becomes available. Check the CDC website for the most recent recommendations to inform planning).

 C. Needs

Discuss what new needs might be created by administering 2009 H1N1 influenza vaccine. For example, consider extra sharps disposal, more refrigerator space, and informational brochures for patients. 

If you need assistance, check with local resources such as your local public health department or emergency management agency to find out what they can provide.

Additional Information and Resources:

Free informational brochures available from CDC.  

For additional child-friendly flu-related messages:

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 D. Roles

    Decide who will perform what roles – e.g., assign who does certain important functions (triage/intake, directing patients to rooms, vaccinating, billing, completing the vaccination record card, immunization registry data entry and monitoring for and reporting of adverse effects).

    Develop a contingency plan.

    • Assign backups to each role.
    • Train staff as needed (it may be necessary to augment staff and/or cross train staff to perform multiple functions).
    • All staff should document their responsibilities and the location of their supplies.
    • Post responsibilities in the office or create job checklists.

Additional Information and Resources:

Staff augmentation strategies to consider (note - these efforts should be coordinated with local public health efforts that may also be planning to use the same sources of additional staff for community-based clinics):

  • Make a list of retired nurses and contact them to come in and assist with clinics.
  • Use volunteer nurses and members of the Medical Reserve Corps (MRC) or Emergency System for the Advanced Registration of Volunteer Health Professionals (ESAR-VHP).
    • To find a MRC unit in your area go to: more about the MRC . For more information on ESAR-VHP, please contact your state coordinator.

When considering cross training staff or using volunteers to provide vaccines, remember that just-in-time training (JIT) – brief, usually on-site training for a specific job function – may be needed particularly for volunteers who typically treat adult patients.

The California Department of Health Services offers a series of videos providing guidelines on proper needle size, site, and techniques for vaccine administration to children and adults.

For information on immunization practices and techniques or to order training videos: Immunization Practice Toolkit

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E. Unusual Situations

Consider unusual situations. Some possibilities may include:

  • Media requests related to your vaccination policies and plans
  • How will your practice address the issue of vaccinating community members that are not typical patients (e.g., walk-ins, caretakers of at-risk patients)?
  • Facility Security

F. Backup Plans

Determine what your backup plan will be if you become overwhelmed due to surge in patient visits and/or unexpected demand for vaccination.

What other organizations or persons (e.g., providers, public health, healthcare facilities) should be included in discussions of your backup plans? Write down these contacts and their phone numbers.

G. Educate and Inform Patients

Discuss how you will inform patients of your vaccine administration plan and which patients need to be reached first.

Inform your high-risk/targeted patients as soon as possible about their need for 2009 H1N1 influenza vaccination.

Identify and educate those patients that should not receive this vaccine (those who have a severe (life-threatening) allergy to chicken eggs or to any other substance in the vaccine).

Additional Information and Resources:

A Vaccine Information Statement (VIS) for the 2009 H1N1 vaccine will be made available on the CDC website.

Other communication/education options to consider:

  • Record a message that will play while patients calling in are on hold and when the office is closed that explains your plan to provide 2009 H1N1 influenza vaccine.
  • If your office has a website, keep it updated with information on your vaccine administration plan.
  • Send a letter to your patients outlining the procedures they should follow to receive a vaccine. Contact your local public health department to ask if they have letter templates available.

H. Communication

Talk to your local hospitals and public health partners and let them know about your plan.
In kind, think about what information you would like to hear from them.

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Vaccine Safety Monitoring

Educate yourself on the Vaccine Adverse Event Reporting System (VAERS) and the procedures for submitting a report. Report forms are available online or can be obtained by calling 1-800-822-7967. Patients are also able to make reports to VAERS if they feel they have an adverse event to report.

Contact your local health department to learn if they have a plan to respond to vaccine safety concerns from providers. This plan should include prompt reporting on clinically significant adverse events to VAERS.

Plan for calls or questions from patients related to the safety of the 2009 H1N1 influenza vaccine and potential adverse events, including questions about its similarity to the 1976 flu vaccine and use of certain ingredients.

Refer to the Vaccine Safety Planning information provided by the CDC.

Additional Information and Resources:

Providers with Vaccine Safety concerns may also contact CDC at 800-CDC-INFO (800-232-4636).
Evaluation:  Evaluate your progress

Plan for how you will track and record the number of patients you will vaccinate.

Additional Information and Resources:

Discuss what impact vaccination had on the clinic and what would need to be improved or resolved for the next time (After Action Performance Review).

Important Contacts Template

Function (What) Name Phone Number/ Email
Public Health Vaccine Contact    
Vaccine adverse event reporting: VAERS    
Emergency Management Contact (supplies, power)    

Acronyms

  • ABN: Advanced Beneficiary Notice
  • AAP: American Academy of Pediatrics
  • ACIP: Advisory Committee on Immunization Practices
  • CDC: Centers for Disease Control and Prevention
  • COOP: Continuity of Operations Planning
  • CPT Code: Current Procedural Terminology Code
  • CRA: Countermeasure and Response Administration
  • EMAC: Emergency Management Assistance Compact
  • ESAR-VHP: Emergency System for the Advanced Registration of Volunteer Health Professionals
  • FDA: Food and Drug Administration
  • HHS: Health and Human Services
  • HR: Human Resources
  • ICS: Incident Command System
  • IIS: Immunization Information System
  • JIT: Just-In-Time (Training)
  • MRC: Medical Reserve Corps
  • PCMH: Patient-Centered Medical Home
  • PREP Act: Public Readiness and Emergency Preparedness Act
  • RBC: Retail-based clinic
  • UCC: Urgent Care clinic
  • VAERS: Vaccine Adverse Event Reporting System
  • VIS: Vaccine Information Statement

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