Register, probably within the next month, soliciting research proposals addressing these issues.

The NIH is currently planning to expand studies of the natural history of HIV infection in women using a two-stage approach. The first stage will include short-term projects that can be initiated during FY 1991 and continued during FY 1992 to collect and analyze data that already exists in women's health clinics and to analyze data from existing cohorts for gender differences. The results of these short-term projects will provide the foundation for the design of a long-term study of a full cohort of women which is projected to begin late in FY 1992.

MINORITY AIDS EFFORTS

Question. Dr. Mason, the PHS is to be commended for its recognition of the disproportionate impact AIDS has had on minority communities. However, I am concerned about the coordination and duplication of programs targeted at minorities at risk. The budget justification from OMH says: "grants are made to national minority and community-based organizations to conduct health education and prevention activities directed to minority groups. (p.31) The CDC justification says that the CDC Office of Minority HIV Policy Coordination is "providing funds directly to approximately 100 national, regional, and community-based organizations which represent or serve minority populations." (p.95). How do these differ? is the reason for separate administration of these programs?

What

Answer. CDC's direct-funded community-based organizations (CBOs) serving racial and ethnic minority populations must be nonprofit and must serve minority populations within the 31 high AIDS incidence metropolitan statistical areas, and the memberships of their governing bodies must have at least 50 percent racial and minority representation. CBOs currently funded by Office of Minority Health (OMH) may serve high, medium or low HIV incidence geographic areas, both urban and rural. OMH tends to fund organizations in areas with a lower incidence of HIV/AIDS. OMH-funded grants range from $50,000 to $75,000 annually, compared with CDC's which range from $20,000 to $225,000 annually.

Both CDC and OMH maintain ongoing collaboration to ensure that grantees of either agency are not funded to conduct the same activities. This is essential in ensuring that funds are wisely allocated and that a range of community needs are addressed.

CDC and OMH are currently discussing the relative benefits of separate administration, conjoint administration or the transfer of the OMH program to the sole administration of CDC. It is quite possible that OMH will merge and/or transfer its national and local HIV grants program with those of CDC.

Question. Similarly, the OMH justification says that it will 'continue to support data collection and studies related to the knowledge, attitude and behavior of minority populations relative to AIDS as well as the incidence of AIDS among minority groups." (p.31) At the same time, the CDC justification lists numerous surveys to assess HIV knowledge and attitudes (p.96). How are these different and how are these coordinated? Could they be merged and save on the additional administrative costs?

Answer. The CBOs funded by either OMH or CDC may be involved with data collection and studies as part of their activities; these efforts are likely to represent different research methodologies and sample populations.

Merging efforts in at least some of these research areas in which it is feasible may benefit both CDC and OMH, as well as enhance the quality of data collection, replications and interpretation.

This is being investigated as part of the initiative to develop a single administration for all of these efforts.

Question. Dr. Mason or Dr. Roper: The CDC budget reflects significant increases in prevention programs for a range of diseases; but funding is level for HIV. Given the epidemic nature of HIV, why hasn't the CDC request included increases in prevention activities? The President's budget states that prevention activities overall go up only 1% while income support rises by 36% and treatment spending rises by 24%. Wouldn't it make sense to increase prevention activities in hopes of stemming the tide of this rise in entitlement spending?

Answer. The Administration had many competing health problems from which to choose. We are currently investing a substantial amount of resources in HIV/AIDS activities, greater than almost any other disease. HIV/AIDS has been receiving substantial increases for the past several years. We believe that this year it important to address some of the other health priorities. I would add that both NIH and ADAMHA have broad authority to reprogram funds between AIDS and non-AIDS and will do so if unparalleled scientific opportunities arise.

RYAN WHITE CARE FUNDING

Question. Dr. Mason: No increases are requested for funding of the Ryan White CARE programs at HRSA and CDC. Given the rising number of AIDS cases and the increasing burden on our public hospitals as reported in recent studies, why is the Administration not increasing funding for these programs?

Answer. In FY 1991 Congress authorized a total of $855 million for the activities under the Ryan White legislation, For this authorization, Congress appropriated $323 million. We have continued these programs at the same level as Congress, although we remain concerned about a fragmented, disease-specific approach to providing health care. I would also note, that through the Medicare and Medicaid, we will invest a substantial amount in AIDS treatment services. In FY 1992 we estimate we will spend $1.36 billion, an increase of 30 percent over FY 1991.

Question. Dr. Mason, I would like to follow up with a question regarding Title III of the CARE bill, which provides for early intervention services for people with HIV infection. As you know, these services are designed to provide testing, counseling and drug treatment that will delay the onset of full-blown AIDS. In its budget justifications, the NIH reported that there is "an apparent decrease in the expected incidence rate of AIDS in the U.S. population. This decrease was abrupt and began in 1987. The most plausible explanation for the decrease is the impact of therapy on preventing seriously immune compromised persons from progressing to AIDS....It is noteworthy that decreases were most prominent in groups with the best access to care, but were not seen in groups (e.g. drug abusers) who have limited access to therapy." (p301) This would seem to underscore the need for expansion of the early intervention programs in Title III, since this is what they were designed for. Why hasn't the PHS requested more funding in this area?

Answer. We have multiple health problems in the United States that need to be addressed. The FY 1992 for Ryan White is maintained at the FY 1991 level and budget increases are directed to other high priority areas such as Project Healthy Start, National Health Service Corps Recruitment, and the Health Care for the Homeless. Some of these programs also will increase services for people who are HIV infected, although they are not specifically targeted for this group.

Question. Dr. Roper, how much money did the CDC request of the Assistant Secretary for HIV programs, as compared to the final level

forwarded in the President's budget? If it was more, areas were cut to meet the President's level?

what program

Answer. CDC initially submitted an FY 1992 HIV budget request to PHS in the amount of $602,153,000 compared to the Administration's request of $494,660,000. While this is the same level as the FY 1991 enacted, it is still an increase of 12.2 percent over FY 1990. While some individual activities will be decreased, others will increase. We will increase research by $3 million to assess the effectiveness of outreach on drug users and their sexual partners. Reductions will be required in CDC's proposed efforts directed to: improving HIV infection reporting; preventing HIV infection among women and infants; preventing HIV infection among minority and outof-school youth; expanding HIV prevention efforts directed to injecting drug users; notifying sex and needle-sharing partners of HIV-infected individuals; decreasing morbidity and mortality from opportunistic infections among persons infected with HIV; enhancing international HIV prevention capacity; preventing HIV infection in the workplace; assisting national, state and local organizations to better utilize social marketing and media; and assuring the capacity of the nation's laboratories to provide CD4+ testing performance, monitoring and training.

Question. Dr. Roper, how much counseling and testing will funds in the FY 1991 budget provide? In FY 1992, with the addition of early intervention services requirements but level funding requested by the President, how much less counseling and testing will be provided? In the professional estimation of the CDC, how much additional money would be required in Title III to maintain the current level of testing and counseling and provide early intervention services for those who need them?

Answer. CDC's FY 1991 cooperative agreement funds for counseling, testing, referral, and partner notification activities ($102,000,000) are only slightly higher than FY 1990 levels ($100,674,173). In FY 1990, publicly funded counseling and testing sites performed approximately 1.5 million HIV-antibody tests of which nearly 57,000 were positive. If trends since 1988 continue through FY 1991, CDC projects that nearly 1.9 million HIV-antibody tests will be administered and approximately 72,500 will be positive. Although the CARE legislation requires grantees to expend at least 35 percent of their formula grant awards on counseling, testing, referral and partner notification (CTRPN)-related activities, they are also required to expend at least 35 percent on other early intervention services. However, grantees will have a great deal of latitude on allocating the remaining 30 percent, i.e., they may expend all or a portion of it on CTRPN-related services or other early intervention services or a variety of optional services. If the states only allocate the required minimum 35 percent of CARE grant funds are available for HIV-antibody counseling and testing (C/T) in FY 1992, then an estimated 1,235,000 fewer tests would be performed compared to FY 1991. However, if all states expend all of their allowable discretionary funds (30 percent) for C/T in addition to the 35 percent minimum mandated by the CARE Act, an estimated 665,000 fewer tests will be performed. An additional reduction of up to 10 percent (190,000 tests) would occur if states expend an estimated $10 million on CD4 cell testing. The CARE Act includes CD4 cell testing services. States are only required to expend a minimum of 35 percent of their CARE formula grant funds on CTRPN-related services and some states may only elect to expend the minimum. Therefore, to ensure that no state receives less under the CARE Act for CTRPN-related activities exclusively, funding levels will have to be increased by $186,391,891 to $288,391,891 in FY 1992 to ensure that 35 percent of each state's total grant award is equal to the amount awarded in FY 1990 for CTRPN.

SENIOR BIOMEDICAL RESEARCH SERVICE

Question. To help alleviate the problems of recruiting and retaining scientists in the intramural program, NIH, I understand that the Public Health Service has been authorized to appoint 350 biomedical scientists to the Senior Biomedical Research Service (SBRS). Yet to date, no scientists have been appointed. Has this program been initiated and if not, why?

Answer. At the outset, it is important to note that the SBRS is not an NIH-targeted program. SBRS affects the entire Public Health Service (PHS) with many PHS agencies eligible under the law.

Secondly, there has been intense activity over the last several months to develop implementation quidelines which are appropriate not only for our short-term goal of SBRS appointments in the near future, but also for long-term goals to assure that these scarce resources are used productively. This is a complex process which has involved a high level PHS committee and the personal involvement of the Assistant Secretary for Health and the Assistant Secretary for Personnel Administration. The Secretary and his immediate advisors will soon be considering recommendations which have several options and are necessarily complex because of the importance of SBRS to helping maintain the best quality of PHS scientific research. with any complex endeavor, we believe it is appropriate to take sufficient time to come up with high quality results.

As

Question. When will you implement this program, and when will the first SBRS appointee be in position?

Answer. We expect to implement SBRS within the next several

months.

Question. Since the legislative history of the law establishing the SBRS mandates that these positions are for biomedical research scientists, how many of these positions have you or will you assign to NIH?

Answer. NIH will definitely receive a substantial share of the 350 slots. However, it is still too early in the implementation process to determine a specific NIH allocation.

Question. Is it true that these positions were intended to be assigned primarily to NIH? What trade offs or replacements will NIH be forced to make - pick up one SBRS and give up one SES slot Explain.

Answer. While NIH has by far the largest biomedical research component of PHS, the legislation also includes provisions for recruitment and retention of outstanding scientists in the field of clinical research evaluation which is primarily performed in the FDA. To a lesser degree, both biomedical research and clinical research evaluations are also performed in other PHS agencies such as CDC and ADAMHA.

I firmly believe that the SBRS legislation was intended to complement rather than supplant other existing personnel systems for senior scientists. I do not believe that it was the Congress' intent to cause the PHS to lose ground in accomplishing our research mission by offsetting SBRS with SES slots. There is no proposal within the Department to have this occur. We are carefully examining all available recruitment and retention resources including new authorities in the Pay Reform Act of 1990 to maximize our ability to retain and further attract first rate scientists to the PHS.

Question. Do you plan to delegate the implementation and administration of this program at the NIH level, and if not, why?

Answer. The SBRS legislation provides for program direction by the Secretary. I fully expect that many of the implementation aspects of SBRS will be delegated to me. I, in turn, fully intend to redelegate authorities to the heads of participating PHS agencies in appropriate situations where there is no significant value in retaining such authorities at my level. However, it is still too early in the implementation process to determine specific PHS agency delegations.

QUESTIONS SUBMITTTED BY SENATOR DANIEL K. INOUYE

AIDS FUNDING

Question. The CDC has conservatively estimated that 40,000 new HIV infections will occur during the course of this calendar year. We have numerous reports from various health care policy journals about the effectiveness of specific prevention programs in various populations around the country, yet the Administration is proposing no new funds for primary AIDS prevention efforts. Why is the Administration not advocating for any additional funds for programs that help people in changing behaviors to prevent the spread of AIDS? Answer. Our FY 1992 request for HIV/AIDS includes a 3 percent increase for behavioral research. Within the overall 3.5 percent increase requested for HIV/AIDS activities, we afforded the highest priority to biomedical research activities, including the development of new therapeutic agents and vaccines. Nevertheless, developing effective and efficient interventions to help individuals reduce HIV related risk behaviors and adopt and maintain "safer" behaviors is an important public health priority of the PHS, and we continue to seek new ways to increase the coordination and effectiveness of our prevention programs for all persons at high risk of HIV infection.

AIDS PREVENTION RESEARCH

Question. It is my understanding that ADAMHA and particularly NIMH has a central role in researching, evaluating and demonstrating successful ways of preventing high risk behaviors related to AIDS. understand that NIMH is using about half of its resources to address issues related to the neurovirology, psycho-neuro-immunology and neurologic pathogenesis. Isn't this an area that is also being addressed by other Institutes, particularly those at NIH?

I

Answer. NIMH is uniquely qualified to conduct basic research on neurovirology and neurobiology to delineate the effect of HIV on the central nervous system (CNS) and the interaction of the brain and immune systems, areas in which NIMH has long held the lead. NIMH AIDS neuroscience research is also geared particularly to the neuropsychological effects of AIDS.

Up to

A large number of persons infected with HIV experience neurological, cognitive, and behavioral changes and CNS impairment is common by the time the HIV infection has advanced to AIDS. 60 percent of persons with AIDS may eventually develop AIDS Dementia Complex (ADC). Cognitive impairment is the most overt and disabling aspect of ADC which can also include slowness in thought processes, limited attention span, memory impairment, altered consciousness, anxiety, mood changes, seizures, confusion, speech difficulties, motor abnormalities, and paralysis.

A key goal of this work is the development of better prevention and treatment approaches for CNS consequences of HIV infection and AIDS. This work has been conducted both through extramural and intramural research efforts in collaboration with other Institutes such as the National Institute of Child Health and Human Development