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Answer. If the Supreme Court upholds the regulations, the Department will allow 30 days after the dissolution of any injunction for grantees to provide an assurance of compliance including a description of the manner in which the grantee will provide services in compliance with the regulation. While this may seem a short period, grantees have had 3 years to consider the implications of these regulations, including the matter of whether they will comply and the methods they would use to ensure compliance.

Following receipt of this assurance of compliance, including a description of the manner in which compliance will be effected, grantees will be provided an additional 30 days to come into compliance with the requirements of the rules. In a few cases in which physical or financial entanglements between abortion and family planning are so substantial that a longer period is required to achieve compliance, a longer period may be authorized to achieve compliance with this part of the regulation.

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Question. If any Title X providers refuse to comply, does the Department plan to discontinue funding them and if so, how will you ensure that Title X services will be continued without interruption?

Answer. We believe that few if any Title X grantees will refuse to participate in the program if the Supreme Court upholds these regulations. However, should any grantees drop out of the program because they decide not to comply with the regulations, there will be little difficulty in transferring the grant to another grantee in an orderly manner.

VACCINE COMPENSATION TRUST FUND

Question. Dr. Mason, you recently told the National Vaccine Advisory Committee that the FY 1992 budget would not include extra funds for the vaccine injury compensation trust fund in order to pay for the cases of injuries and deaths due to vaccines administered before October 1, 1988.

This Committee has provided over $137 million in the past two years to pay these claims. My information indicates that about $47 million remains available. However, over 4,000 claims have been filed, and it may cost up to $3 billion to pay those claims.

These vaccinations are required by the Federal government. Is it appropriate for the government to compensate families of children injured by the vaccines?

claims?

Answer. Yes, it is appropriate for the Federal government to compensate families of children injured by vaccines.

Question. How do you propose to handle this flood of new

Answer. I have asked the Advisory Commission on Childhood Vaccines to develop a set of recommendations to address the financing issues facing the program. I have asked that any potential revisions to the authorizing legislation should be based on scientific knowledge regarding causation of adverse effects related to vaccines.

Question. Dr. Mason, what do recent medical findings indicate about the correlation between injured infants and the vaccines?

Answer. Approximately five to ten cases of vaccine associated poliomyelitis are reported each year. Some of these are contracted by yet undiagnosed immune deficient hosts.

No good evidence exists for MMR (mumps, measles, and rubella) vaccine associated injury. Isolated case reports of suspected but

unconfirmed "postvaccinal encephalomyelopathy" have appeared in the literature.

No characteristic neurologic syndrome or pathology has been found to follow DTP (diphtheria, tetanus, and pertussis) immunization. Many neurologic illnesses including many of the epilepsies may be present in the first year of life and may coincide with time of immunization. The current literature, however, which includes a number of controlled studies does not allow for a causal association to be drawn between DTP and brain injury, epilepsy, or specifically infantile spasms. One can conclude then, that if serious neurologic illness occurs following DTP vaccination, it must do so so rarely as to be unmeasurable. There are no means at this time by which such an isolated event could be verified. In additions, Sudden Infant Death Syndrome has been studied exhaustively with regard to DTP vaccination, and has not been shown to be caused by this vaccination. A number of benign conditions have been reported, such as the hypotonic hyporesponsive episode--a self limited spell unassociated with death or permanent sequelae.

Finally, while there is evidence that transient arthralgia and arthritis can in some individuals follow rubella vaccination, it has not been shown that chronic arthritis results.

While anaphylaxis could conceivably occur following any immunization injection, its occurrence in the first year of life is decidedly rare and would not be expected to occur following first exposure to a vaccine.

Question. Will the Administration be seeking legislation to clarify the Federal responsibility to the families of children who were injured or died as a result of vaccinations given before October 1, 19887

Answer. At this point, we have not developed any such legislative proposals.

HIV/AIDS INFORMATION/PREVENTION

Question. The budget request for HIV/AIDS information and education activities and preventive services within OASH includes no funds in either FY 91 or FY 92 for preventive services for high-risk persons; no funds for prevention capacity enhancement; no funds for activities targeted to school- or college-aged youth; no funds for education of health care workers and providers; and no funds for activities aimed at the general public. Only special minority initiatives appear to merit funds. Do you believe this budget reflects the national scope of the AIDS problem accurately?

Answer. With the exception of HIV/AIDS activities carried out by the Office of Minority Health (OMH), OASH/HIV responsibilities are limited to policy development, oversight, and coordination of PHSwide HIV/AIDS activities.

Question. Why are no funds requested for any other prevention or education activities in OASH?

Answer. All of the PHS prevention programs other than those funded by OMH, whose focus is on minority AIDS, are operated by the PHS agencies, primarily CDC.

OFFICE OF MINORITY HEALTH

Question. Both the Office of Minority Health and the CDC Office of Minority HIV Policy make grants to national, regional, and community-based organizations serving minority populations; and both

collect data and conduct studies about AIDS in minority groups. How do the activities of these offices differ, and what is the rationale for supporting two separate offices to do the same things?

Answer. The Office of Minority Health HIV/AIDS grants program is different from that of the Centers for Disease Control in that CDC grants target organizations in metropolitan areas with the highest prevalence of AIDS cases, while OMH does not restrict its funding based on the geographic location (urban/rural) of the potential grantee. In fact, OMH tends to fund organizations in areas with a lower incidence of HIV/AIDS. In addition, OMH-funded grants are considerably smaller than CDC's, ranging from $50,000 to $75,000 annually compared to CDC's which range from $20,000 to $225,000 annually. OMH also looks for racial/ethnic diversity in grantees and target populations when making its funding decisions.

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.

As minority HIV/AIDS issues and their impact across geographic areas continue to blend more closely with the missions of OMH and CDC, it is the intent of OMH to merge and/or transfer its national and local HIV grants program with those of CDC.

SEXUAL ACTIVITY AMONG TEENAGERS

Question. Your budget proposes a 54% increase in funds for the Adolescent Family Life program, from $7.8 million to $12 million. This program aims to prevent or reduce sexual activity among teens.

Yet a recent CDC study has shown that more young women than ever are having premarital sex in their mid- to late teens, in spite of their knowledge about the risks of doing so, such as AIDS. The CDC didn't study young men, but it's hard to believe their situation is different.

The Adolescent Family Life demonstration program is 10 years old. Is the program working?

Answer. The Adolescent Family Life (AFL), program is required by statute to expend at least two-thirds of its demonstration funds on projects which demonstrate methods of providing care to pregnant and parenting teens. Thus, less than one-third of the AFL program demonstration funds are permitted by law to be directed toward prevention or reduction of sexual activity among teens.

Teen sexual activity rates are indeed rising. This trend reflects a change in behavioral standards in families, in representations of behavioral norms in the media, and, as a result, changes in the values of teens themselves. It is unrealistic for a program the size of the AFL prevention demonstration component to be expected to reverse the national trend toward increasing sexual activity among teens, and in fact, AFL is not expected to have this effect. Rather, the AFL demonstration program is designed to develop models for families and communities to use in trying to reduce or prevent early sexual activity.

The AFL program has done this. Programs such as Postponing Sexual Involvement in the State of Georgia and the Illinois Commission on the Status of Women's Project Respect, have been supported by AFL. Both demonstrate that in specific communities which dedicate themselves to resolving these issues, the national trends can be slowed or reversed.

There are really only two ways of dealing with the problems of adolescent pregnancy and the teen epidemic of sexually transmitted diseases. One is to promote contraception and provide contraceptives

and hope that teens will use both oral contraceptives as preventers of pregnancy and condoms as protection against sexually transmitted diseases. The other is to support the AFL approach of trying to develop models to encourage abstinence, and supporting families and communities to adopt postponement of teen sexual activity as a realistic, necessary and achievable goal. Contraception should be available for teens who decide to become sexually active, but emphasizing that teens have the choice not to become sexually active is still the intervention of choice.

GOALS OF SEX EDUCATION

Question. A study of the impact sex education has on sexual activity, contraceptive use, and teen pregnancy found that teens who are exposed to sex education aren't any more likely to be sexually active than other adolescents. But they are significantly more likely to use contraceptives, and less likely to become pregnant than those who have not taken a sex education course. What is the

appropriate goal for these programs: should the goal be teaching responsible sex education and family planning?

Answer. There have been many studies on the impact of school based sex education programs and, overall, no consistent effects on adolescent sexual activity, contraceptive use and pregnancy have been found. The most recent--Kirby, Waszak and Ziegler, Six SchoolBased Clinics: Their Reproductive Health Services and Impact on Sexual Behavior", Family Planning Perspectives, Vol. 23, No. 1, January/February 1991--found no effect on the onset of adolescent sexual activity, varying effects on contraceptive use, and no effect on pregnancy rates.

The factors that influence early adolescent sexual activity, contraceptive use and pregnancy are complex and not well understood. However, we do know that contraceptive based sex education programs have not had any significant impact on the problems of adolescent sexual activity and pregnancy. In addition, people in many communities feel that these programs, especially when school based, create an environment in which adults and authority figures appear to condone early sexual activity as long as contraception is used.

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Given the research on this subject and the fact that adolescent sexual activity, the incidence of STDs and AIDS in the adolescent population, and out-of-wedlock births to adolescents continue to increase from already alarming levels, it seems unlikely that increased provision of contraceptive based sex education programs is the answer to these problems.

DUPLICATION IN OASH PROGRAM OFFICES

Question. Several program offices within the Office of Assistant Secretary appear to be duplicative of other programs in PHS. For example, the National Vaccine Program Office works on improving our vaccine capability, as does NIH, CDC, and FDA. The Office of Minority Health aims to improve the health status of minorities, the same goal as several HRSA and CDC programs. The Office of Minority Health even has a special AIDS unit, separate from your National AIDS Program Office which itself is separate from the AIDS research and care programs. You can probably see where I'm heading Are these offices truly necessary within the Office of the Assistant Secretary, or should we be targeting funds to the programs themselves?

Answer. The Assistant Secretary for Health (OASH) believes that these offices are essential in assisting him to manage the PHS effectively as they:

(1)

(2)

coordinate complex and high visibility activities occurring in several PHS agencies, encouraging interagency communication and helping to avoid interagency duplication and

provide visibility for an important issue at the highest level
within PHS to assure that the ASH is kept aware of developments
concerning the issue and to facilitate clear
communication/coordination with, for example, the Secretary,
other parts of the Department, other Federal departments and the
private sector.

In some cases, there are legislative requirements for the program office (or its head) to be located in OASH. For example, P.L. 94-317 established the Office of Disease Prevention and Health Promotion in OASH in 1984. The position of the Deputy Assistant Secretary for Population Affairs is legislatively located in OASH (P.L. 91-572). In 1990, the position of Deputy Assistant Secretary for Minority Health (who directs the OASH Office of Minority Health) was established within OASH by the Disadvantaged Minority Health Improvement Act of 1990, P.L. 101-527.

Proposals to establish new program offices in OASH are always reviewed carefully within PHS to ensure that duplication does not occur; these proposals are also submitted to the Office of the Secretary for approval. In addition, we periodically examine the organizational structure of the Office of the Assistant Secretary for Health to verify that each OASH program component should remain at this organizational level.

Funds certainly should be targeted to the programs themselves, but to ensure that these programs are efficiently administered by the PHS agencies, it is essential to have these small coordinating offices at the OASH level.

Question. If an Assistant Secretary-level office is important for coordination in the Department, would moving the Office of Rural Health Policy to the Assistant Secretary's level help with efforts to improve rural health care?

The

Answer. At the present time, there is no reason to move the Office of Rural Health Policy (ORHP) to the Assistant Secretary's level since ORHP's current location in the Health Resources and Services Administration (HRSA) is practical and is working well. Director, ORHP reports directly to the HRSA Administrator and, from that position within the Office of the Administrator, has the advantage of being able to coordinate and have an impact on rural health programs.

HRSA provides a supportive environment for ORHP activities which include managing a departmental telecommunications demonstration project, administering several grant programs, and sponsoring workshops and conferences to focus on rural health issues. ORHP coordinates departmental rural health research as well as the PHS responsibilities pertaining to the rural economic development activities of the Secretary's Policy Council. In addition, ORHP is involved in several collaborative efforts with other Federal

agencies.

ORHP has established good working relationships with the Health Care Financing Administration (HCFA) regarding the coordination and review of HCFA policies which impact on rural health care. provides technical assistance to HCFA in the design and implementation of HCFA grant programs aimed at assisting rural hospitals.

ORHP

At the discretion of the Assistant Secretary for Health, additional coordinative efforts can be carried out by ORHP without changing its organizational location. Since ORHP is effectively carrying out its responsibilities, I believe that the HRSA location offers the most advantages. It allows ORHP to carry out policy and

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