Press Briefing Transcripts

Weekly 2009 H1N1 Flu Media Briefing

September 18, 2009, 12:00 p.m.

• Audio recording (MP3)

NOTE: This is a rough, unedited transcript and transcription errors may appear.

CDC Press Conference, Friday, September 18, 2009

Operator: Welcome and thank you for standing by.  At this time we're in listen-only mode.  During the question and answer session today you can press star 1 to ask a question.  Today's conference is being recorded.  At this time I'll turn the call over to Mr. Glen Nowak.  You may begin, sir. 

Glen Nowak:  Thank you.  And thank you all for joining us this afternoon for our weekly update on H1N1 flu.  Today we have Dr. Daniel Jernigan, a medical epidemiologist who is the deputy director of our influenza division here at the Centers for Disease Control and Prevention.  Dr. Jernigan will be providing an update on the H1N1 flu and seasonal flu in the United States as of today.  We are also joined today by Dr. Jay Butler, a medical epidemiologist at credited and he is the chief our 2009 H1N1 vaccine task force.  Dr. Butler will be giving an update on where we stand with respect to the 2009 H1N1 vaccine and its availability and distribution.  I will start by turning the mike over to Dr. Dan Jernigan to give an update on the current flu situation in the United States.  Dr. Jernigan? 

Dan Jernigan: Thank you very much.  Well, the flu season has begun.  It's begun early, and nearly all of the influenza that we're seeing is this novel H1N1 virus.  What we see are the children and young adults are still being hit the hardest, which is something we saw in the spring, and it's showing itself again in the fall and in the late summer here in the United States.  We are finding that there is flu being reported in all 50 states.  There are 21 states that are reporting widespread activity.  We don't see that kind of activity this time of year usually.  It's a very strange thing for us to see that amount of influenza at this time of year.  We monitor the numbers of patients that go into certain emergency clinics and outpatient clinics.  And with that information we can see if there's increases in the numbers of people coming in with flu.  And what we find is that there is an increased amount of folks that are coming into the clinics with influenza.  It's about twice at least what we would expect for this time of year.  If you talk to doctors, they'll tell you, boy, I'm seeing lots of flu at this time of year.  That's something we do not see normally but we don't want to look only at what's happening in the outpatient setting.  We want to also look at what's happening in hospitalizations, in hospitals.  And what we see so far is there is some increase in the rate of hospitalizations for younger children and for adults, but it is not up at the same levels that we would see during seasonal flus.  So it's something we want to watch very closely.  But at this time we're seeing lots of activity in the outpatient setting and seeing some activity in hospitals. 

We look at all of the viruses that are turned in to CDC from multiple different laboratories around the nation and around the world, and what we've found is the vast majority of the influenza virus that are circulating are the novel H1N1.  So far we find that the virus that's circulating right now is a good match to the new vaccine that's being developed and being manufactured and distributed.  We also find that the virus still maintains a high level of susceptibility to Tamiflu, or oseltamavir, the anti-viral drugs used to treat it.  We're also encouraged that we don't find any changes in this virus that would suggest that there might be increased virulence, that is, increased severity of disease because of changes in the virus that might occur.  I think we certainly do expect to see a whole lot more illness in the coming weeks and throughout the U.S. flu season.  We expect that if the H1N1 remains the predominant strain that more younger people will be affected than we might think -- or might see in the past.  In the past in flu seasons older individuals are often more affected, but we may see that younger individuals are more affected this year.  So that's something we want to watch very carefully and also another reason why it's important to get vaccinated when the vaccine becomes available. 

Unfortunately, because there will be lots of cases of moderate disease, we will have some hospitalizations.  We will also have some deaths that will be due to the H1N1 and to influenza this year.  That's something that we expect, something that we want to prevent with vaccination.  Flu activity will vary.  So some parts of the country will have disease, while some parts may not.  We may see waves of disease going from one part of the country to another.  In the southeast right now there's a considerable amount of influenza disease, very consistent with the opening of schools earlier in the southeast.  As schools opened after Labor Day, we may expect that increases in numbers of cases will occur in other parts of the country, where kids are now getting back together. 

Most of the illness, like I said, appears to be moderate or moderately severe.  And that's good news, but it's not always the case, and it could change, and that's why we want to monitor the virus and monitor disease very closely, in case there's anything that suggests that this virus is changing.  Prevention, of course, is the most important thing.  We know that flu viruses can cause severe illness.  And so the first thing that one can do right now is to get seasonal vaccine.  The seasonal vaccine is out there.  It's in doctors' offices.  So make an appointment to get the seasonal vaccine if you're indicated to get it.  It's especially important for people that are over age 50, for children, pregnant women, and people with underlying conditions like heart and lung diseases.  This year we expect 115 million doses to be available.  There have been apparently 54 million doses already distributed.  And in many places providers have seasonal flu vaccine, they have it now, but there will be more distributed so folks will be able to find it. 

Of course, vaccination is the most important thing to do, but there are other things that you can do.  That includes taking regular precautions like washing your hands, covering your cough, and staying home when you're sick.  And also, if your doctor recommends, you should get anti-viral drugs, then that's something you should do.  As a physician myself I think it's always better to err on the side of being healthy than sick, and so taking those precautions like getting vaccinated, making sure you're using appropriate hand hygiene and cough etiquette, and taking anti-viral drugs if your doctor recommends them are things that are very important, but also to take advantage of the safe and effective H1N1 vaccine when it becomes available.  With that I'll hand this over to Dr. Butler. 

Jay Butler: Well, thank you, Dr. Jernigan.  And good afternoon, or good morning for those of you on the line. This morning, this afternoon I'd like to provide an update on the status of the H1N1 vaccine program.  A couple of events have developed over the past week which I think are important.  The FDA has licensed the H1N1 vaccine from four of the five manufacturers, and that's one of the important steps towards making the vaccines available.  We also have data now that there's a good antibody response to the vaccines, that adults appear to have a robust antibody response that suggests that a single dose should provide protection.  And additionally, there's been no mutation in the virus.  So right now there's every indication that we have a good match between the virus that's causing disease and the vaccines we have to be able to prevent it.  And that's critical to be able to anticipate that we'll have a very effective vaccine for prevention.  The H1N1 vaccine is an influenza vaccine.  It's pretty much identical to the seasonal flu vaccines.  It's just directed against this new virus.  It raises the question of why isn't it in the seasonal flu vaccine this year?  Simple reason is the virus didn't exist at the time that the seasonal flu vaccine was being formulated.  So this has been able to be developed very rapidly, and we anticipate that it will be available during October.  We actually anticipate being able to start receiving orders for the vaccine in -- by early October.  And actually, vaccine going out and being distributed by providers by the first week of October.  The distribution process is fairly complex.  The government has purchased 195 million doses.  It's a very large logistical undertaking.  You have to get this vaccine from five manufacturers out to some 90,000 provider sites around the country.  Initially, we anticipate that about 3.4 million doses of vaccine will be available.  Additional vaccine may be available as well, but 3.4 is the hard number that we have right now.  And all that vaccine is the live attenuated vaccine, which is the nasal spray.  Same type of vaccine as the nasal spray vaccine that's used for the seasonal flu vaccine, but it's directed against the H1N1 virus.  The centralized distribution system is one that's very similar to what's used currently for the federal Vaccines for Children program.  This distributes federally purchased vaccine out to about 40,000 sites nationally already.  So this system has been enhanced, and there's been outreach at the state level to be able to enroll additional providers to be able to administer the vaccine. 

This is a voluntary vaccination campaign.  People have the opportunity to get vaccinated.  Our goal is to ultimately make the vaccine available to every American who wishes to be vaccinated.  The vaccine demand is hard to predict.  And certainly, as the rates of disease have gone up, we've become more and more concerned about making vaccine available as soon as possible to those who wish to receive it, to agencies that wish to be able to administer it.  And there's a balance there, recognizing that there's demand, there's ability to administer it, and we also have disease.  And in finding that time to start the program is certainly a challenge, but we want to be able to make vaccine available as it's becoming available for shipment through the distribution process. 

As Dr. Jernigan mentioned, I don't want to take anything away from the importance of vaccination against seasonal influenza.  Other strains of influenza probably will be circulating this winter as well.  We've heard a lot of talk about what's going to happen, when peaks will occur.  I think Yogi Berra said it's very hard to make predictions, particularly about the future.  There's much that we don't know about the epidemiology of the disease.  We are getting a better handle on the availability of the vaccine.  And we anticipate that the amount of vaccine that's available will continue to increase as the season moves on during October and through November, and that ultimately anyone who wishes to be vaccinated would have the vaccine available to them.  And with that I think I'll stop and I'll be happy to take your questions, as will Dr. Jernigan. 

Glen Nowak: Thank you.  We will start with a question from the room.  Mike Stobbe? 

Mike Stobbe: Thanks.  Mike Stobbe from the AP.  Dr. Butler, to go over what you just said 3.4 million doses, were you referring to early October?  And how many providers are going to get that?  I'm trying to figure out the logistics. 

Jay Butler: Again, 3.4 is sort of the hard bottom number.  We may have additional doses of injectable vaccine available by then, but that information is still forthcoming from the manufacturers.  The number of providers will be determined by the orders that come out of the state.  The system has been set up to be able to provide maximum flexibility to address the fact that health care delivery and health care systems and even public health is different in different regions of the country and there's differences state to state.  One size doesn't fit all.  So this allows the states to be able to dictate how much vaccine comes into their jurisdictions, at what time, and to whom. 

Mike Stobbe: What's your best guess?  How many providers will be getting those 3.4 million doses? 

Jay Butler: Well, there's 90,000 distribution sites ultimately.  How many of those are providers versus then situations such as a retail chain that will then redistribute it among their outlets, I don't have a good handle for that yet.  I think it's important to recognize that the 90,000 is not always a provider's office but it may be a point where the vaccine will then be distributed even further within a jurisdiction or within a company. 

Glen Nowak: Thank you.  Operator, we will take a question from the phone. 

Operator: Thank you.  If you'd like to ask a question on the phone lines, press star 1.  Our first question comes from Miriam Falco with CNN Medical News.  You may ask your question. 

Miriam Falco: Thank you for taking the questions.  I have two.  Number one, are you encouraging folks who aren't in high-risk groups to wait?  Obviously, with the first wave being the live attenuated virus it eliminates people who are younger than 2 and older than 49 and pregnant women.  But are you encouraging folks to wait if they aren't in those high-risk groups?  And secondly, I know the vaccine was approved at 15 micrograms.  One shot is what was needed.  Is that going to be what everyone's going to get, pregnant women and children?  Can you clarify what -- how many shots people will get? 

Glen Nowak: Sure.  I will have Dr. Butler answer those questions. 

Jay Butler: Yeah, the Advisory Committee on Immunization Practices provided recommendations on who should receive the vaccine first based on the epidemiology of disease, who's at highest risk.  And I think probably everybody's aware of those groups in general.  It's younger people, adults with underlying illnesses, and people who are at risk of transmitting the illness, such as health care workers or people who live with or care for infants younger than 6 months of age, an age at which vaccination is not possible.  The recommendations are out there.  And I think an important factor to keep in mind is there's no magic to this.  This is a huge logistical process.  And there's not a sudden appearance of vaccine in 90,000 refrigerators around the country.  So in general, the recommendations are the people who are in the highest risk groups are the ones who should be vaccinated first.  But in any given location the availability of vaccine may actually vary.  So oftentimes, that decision of who was actually administered the vaccine may be ultimately decided by the provider and the patient.  The recommendations are out there, though, that the highest-priority groups are those impacted by disease.  And those are the groups outlined by the ACIP.  The question about number of doses, the package inserts, our reading that a single dose would be required for people age 10 and older, we anticipate that two doses will be required for younger children, and this is pretty much the same case as occurs with seasonal flu vaccine. 

Glen Nowak: And we'll take a question from the room. 

Kip Grossman: Hello.  Thank you for making time.  My name's Kip Grossman for Fox News Channel.  A question for Dr. Jernigan.  Curious if you're aware of the work of Dr. Lipsitch from Harvard and if you could comment on that. 

Dan Jernigan: The work of Dr. Lipsitch is based on some collaborations we had with him over the spring and in the summer.  That work is looking at how severe is the pandemic and what are some estimates.  And so we -- we were able to provide some of the information to that.  But the estimates in that are the work of Dr. Lipsitch and not necessarily from the federal government.  But they do indicate that the amount of disease is about what we would expect for a severe influenza season and not at the levels of the pandemics from 1918 or 1957. 

Kip Grossman: Well, on the face of it, that would sound like good news.  Would you agree with that? 

Dan Jernigan: Well, it is good news in that it corroborates what we've been seeing with all the surveillance, what we've been seeing from the anecdotes from doctors and the reports of cases.  The concerning things, of course, are that there appear to be some differences with this virus and how it infects the lungs.  That's something we want to watch very closely.  It may than there is a small subset of patients that when they do get sick who go on to have very severe disease, it doesn't minimize the fact that influenza kills and causes disease in a lot of people every year.  And so even a moderate influenza season has a lot of morbidity and mortality.  And so we don't want to lose that in this.  It's encouraging, but we know that influenza viruses can change very quickly.  They've done that in the past by switching to be completely resistant or completely changing the subtype.  And so we have to monitor this quickly so that we don't have something that appears to be what happened many years ago when there was fairly moderate disease and then a change in the character of the influenza.  So we want to be prepared, but we are encouraged. 

Kip Grossman: Does this change the way you behave moving forward? 

Dan Jernigan: We have been moving forward by using the information that we get, letting the science direct us, letting the surveillance information tell us about the virus, looking at patients and then letting that determine how we act.  But at all times being prepared in case something changes. 

Glen Nowak: Operator, we'll take another question from the phone. 

Operator: Thank you.  This question comes from Stephen Smith with "Boston Globe."  You may ask your question. 

Stephen Smith: Hi.  Good afternoon, and thanks for taking the call.  In the wake of the PCAST report which came out last month, which as you know for modeling purposes said that H1N1 this fall could result in 30,000 to 90,000 deaths, there continues to be confusion about what to expect from the virus.  And while PCAST insists those figures were not meant to be estimates the reality is in many quarters they have been interpreted as such.  So in CDC are there actual working estimates of how many deaths from H1N1 might result this fall?  And have those changed over time with a better understanding of the virus?  And how should the public and public health officials, for that matter, square these planning scenario figures with the CDC's own data showing that so far there have been fewer than 1,000 H1N1 deaths? 

Glen Nowak: Sure.  I'll let Dr. Jernigan answer that question. 

Dan Jernigan: Yes.  You point out the difference between planning scenarios and monitoring what's going on.  And so we have ways of estimating the numbers of deaths, the numbers of hospitalizations, looking to see what we're seeing with the actual numbers coming in, how do they compare to what we might expect.  Some of that information I think is very close to coming out that we would be able to provide to you.  Similar to how Dr. Lipsitch's information came out as well.  We are likely to have numbers that look very similar to what Dr. Lipsitch had.  But the virus I think we have to continue to monitor.  There's only so much that you can do with forecasting.  It helps us to understand what resources might be needed, what policies might need to be changed.  But we don't want to provide a very specific number because all of those numbers are estimates.  They're based on many assumptions.  So we want that information that comes out to be as realistic as possible.  The -- through the summer we have been collecting a lot of information, have been working with a lot of collaborators, and I think that's really helped us refine the numbers so that they will be as accurate as possible. 

Glen Nowak: Thank you, operator.  I'll take another question from the phone. 

Operator: Our next question comes from Maggie Fox with Reuters.  You may ask your question. 

Maggie Fox: Hi.  Thanks very much.  I want to ask you about how fast the virus is moving and how many people you think can get vaccinated ahead of some of the waves of the pandemic.  Is there any way of people kind of calculating when they're going to get vaccine and whether it's going to be in time?  Thanks. 

Glen Nowak: Sure.  I will have Dr. Butler address that question. 

Jay Butler: Yeah.  Well, that's a great question because it's one of the ones that we always ask as well.  In terms of movement of the virus, I suppose we can say it's gone viral.  It's continuing to -- we're continuing to see increasing rates of disease around the country, and it's one of the reasons why we're concerned about making the vaccine available as soon as possible.  There are certainly technical and logistical limitations, but we want to make that available really as broadly as possible, as much vaccine as possible, as quickly as we can.  In terms of predicting just what that will be, there's a lot of moving parts.  And that's why I really want to talk now.  We're close enough that I think we need to talk in terms of really firm numbers.  Vaccine that has gone through the clearance, lot release process, and that we are beginning to look at actual delivery dates to the distributor.  We will know more really day by day.  It's a very dynamic process.  I would love to be able to give you harder numbers and a more definite answer because that would be very helpful for us for the planning purposes.  And we will know much more a week from now than we know today. 

Glen Nowak: Operator, I'll take another question from the phone. 

Operator: Thank you.  This question comes from Richard Knox with National Public Radio.  You may ask your question. 

Richard Knox: Hi.  Thanks for the chance.  I want to be clear about whether there's any thought of prioritization or guidance for who should get the very first doses when after Kathleen Sebelius said there would be some beginning in the first week of October some CDC people indicated to me that they might need to go to health care workers and first responders.  But it sounds today as though you're saying you're not prioritizing at all and whoever within the ACIP recommendations is eligible for the nasal spray version should get it without any prioritization.  Is that right? 

Glen Nowak: I'll let Dr. Butler clarify that because I think he can correct that. 

Jay Butler: Yeah, there's not a recommendation of subprioritization beyond the level of what's in the ACIP statement.  Primarily for two reasons.  One is there may be state to state differences.  The focus initially, if vaccine supplies are relatively limited on health care providers, makes a lot of sense.  But in some states getting vaccine to health care providers if there's not large hospitals that it would be sent to may be a little more of a challenge.  So we want to be able to provide that flexibility for the local needs to be able to be met. 

Glen Nowak: Thank you, operator, I'll take another question from the phone. 

Operator: This question comes from David Brown with the "Washington Post."  You may ask your question. 

David Brown: Thanks very much.  Can you provide some detail about the logistics of this delivery system and how if a clinic or a doctor or a hospital wants to be one of the 90,000 that gets it, how it gets on the list there?  You know, where the McKesson site is, what the predicted turnaround time from the -- if a batch of vaccine arrives on Monday, how long does it take to say okay, we're now going to divide these 10 million doses among 90,000 different, you know, receivers who all demand different amounts.  You know, just give us some granular sense of how that's going to work and the amount of time it's going to take to process, you know, one batch of one delivery of vaccine. 

Glen Nowak: Sure.  I will let Dr. Butler speak to that question. 

Jay Butler: The ordering process, beginning from the provider, will be a request for vaccine that will go to the state health department.  The state health department immunization coordinator each day will know the allocation of vaccine available to that state.  And at the state and local level the requests will be basically triaged to be able to direct where the vaccine goes, and then those orders will be transmitted daily to CDC, where they'll be collated.  First thing, the day's orders will be transmitted to the distributor, roughly 5:00 a.m. the next morning, and then those orders will start being filled and they'll be filled within three business days.  When the order is filled, it'll be shipped by overnight express from the distributor to the provider, and those shipments will not occur on Friday or Saturday, of course, because we don't want vaccines showing up at locked doors or not being controlled or available.  There are four distribution sites that vaccine will go out from.  And that will help minimize the amount of transit time required.  And I think you asked where those are, and I actually don't know the answer to that question, but they're geographically distributed to be able to provide vaccine to all states and territories as rapidly as possible. 

David Brown: So 3.4 million doses first week of October, 50 states.  If you do the math, that's 68,000 doses per state.  Is that what's going to happen, 68,000 doses go to each state and then they distribute? 

Jay Butler: Keep in mind that 3.4 is the doses that we know will be basically on the pad when we open it.  There will very likely be additional doses.  But we don't know exactly how much will be available yet.  The flow of vaccine the first week or two may be slower than what we would like.  And the balance here is finding the sweet spot.  Do we just hold vaccine in a warehouse until there's lots and we can send it out all at once, or do we start the process earlier?  So we're trying to find the right balance of when we think there will be enough vaccine so that there's not spot shortages, and that that -- just that math that you've done is exactly what we've been doing, too, so those numbers aren't too small. 

Mike Stobbe: And just to clarify the earlier comment, it will be up to each state whether they give it only to health care workers or certain people that first week? 

Jay Butler: Right.  And much of that really is most applicable during that first week when the amount of vaccine may be smaller.  Again, we will know much more as we actually approach the date to begin receiving those orders of exactly how much will be available. 

Glen Nowak: Maybe it would be helpful to clarify.  Are we talking about an equal amount going to states?  Are we talking about a pro rata using population as a basis? 

Jay Butler: The state allocations are based on populations.  It's straight pro rata. 

Glen Nowak: Operator, I'll take another question from the phone. 

Operator: Thank you.  This question from Bridget Desimone with the "News Hour."  You may ask your question. 

Bridget Desimone: Thank you.  Bridget Desimone with the "News Hour."  Do you anticipate that some health care workers are going to resist getting the vaccine?  And how do you deal with that? 

Glen Nowak: I will have Dr. Butler address that question. 

Jay Butler: It's certainly possible some health care workers may choose not to receive the vaccine.  We know that happens with seasonal flu vaccine also.  As a health care worker, actually, I've received the seasonal flu vaccine for more years than I think I can count now, at least 20 in a row now.  I think it's -- personally I feel like it's an important part of quality of care, that it's an opportunity not only to increase your chances of being able to come to work but to decrease your chances of transmitting an infectious agent to at-risk patients.  Certainly there will be health care providers who will decline the vaccine.  And I don't know what proportion that will be. 

Glen Nowak: Next question from the phone, operator? 

Operator: Our next question comes from JoNel Aleccia with MSNBC.com.  You may ask your question. 

JoNel Aleccia: Thanks.  Thanks for taking the call.  You know, we've had so many people come down with H1N1 already.  And the question I seem to be hearing over and over again is they're wondering if they're protected against the virus and if they should still go ahead and get the vaccine when it becomes available.  What advice are you giving them? 

Glen Nowak: Sure.  We'll have Dr. Butler answer that question as well. 

Jay Butler: People who have actually been infected with the 2009 H1N1 virus likely do have some immunity.  But the important issue is whether they know that's in fact what they were infected with.  And the vast majority of cases occur without laboratory confirmation.  It's also important to realize that most -- that many cases of influenza-like illness may not be caused by the 2009 H1N1.  Early in the epidemic we had other strains of influenza circulating.  There are other viruses that can make people ill as well.  So even if someone has had an illness that was similar to influenza, even if there was perhaps a clinical diagnosis of H1N1 infection made, a recommendation would still be to receive the vaccine so you know you're immune.  There's no evidence that even if you have immunity getting the vaccine would cause problems or increase the chances of a reaction.  So that would be our recommendation.  Certainly for myself, if I had been ill in the past six months without a lab confirmation I would definitely want to get the vaccine. 

Glen Nowak: Thank you.  Operator, we have time for one more question from the phone. 

Operator: Thank you.  And that's from Betsy McKay with "Wall Street Journal."  You may ask your question. 

Betsy McKay: Hi.  Thanks very much.  Dr. Butler, a couple more questions about distribution.  One is if we're talking about getting vaccine now in early October, can you tell us what deliveries will be like going forward from there?  Are we still talking about 45 million doses by mid October and 20 million every week after that until 195 million at the end of the year, or has that schedule changed?  And the other question I wanted to ask is if you can tell us what you and/or the states are doing to ensure that the recommended groups get vaccine first.  Like are you able to -- are you planning to steer vaccine to certain providers like OB-GYNs and pediatricians rather than larger clinics or pharmacies? 

Jay Butler: Okay.  Thank you for those questions.  The -- it actually raises a very important point about how to perceive the vaccine distribution program.  It is indeed a flow.  And perhaps the image of a river helps in that you have these five sources coming into a single flow of vaccine.  Ultimately, you have maybe a braided delta with lots of points where ultimately the vaccine is going.  That flow is anticipated to increase as more of the production capacity comes online, more manufacturers are contributing vaccine to the system.  The exact numbers are very hard to nail down, as we've learned.  But we would anticipate that once we're up and going we should be seeing at least 20 million new doses of vaccine weekly going right on into December after the -- when we would hope to reach the capacity of having delivered 195 million doses.  The question about recommended groups is a good example of why the state flexibility is very important.  Some of the states have identified, for instance, maternity hospitals as where they might want to first direct vaccine.  Although the -- If only live attenuated vaccine is available up front, they wouldn't be able to use that for pregnant women.  But if an injectable vaccine is available, they certainly could.  They would also be able to vaccinate people who are very soon going to be living with or caring for an infant younger than six months.  And they could target health care workers also.  Not every state would have an institution that stands out as one that fits that description.  So it's a decision that really does need to be made locally. 

Glen Nowak: Well, thank you all for your participation this afternoon.  We will have the transcripts posted as soon as we can.  Hopefully within a few hours.  And I thank you for participating in today's press briefing.  We are concluded.  Thank you. 

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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES