enhance the National Nutrition Monitoring System's (NNMS) data
collection and analysis program. Some examples of research
areas that will be considered include adapting or developing
clinical techniques for use in the NNMS; the relationships of
body composition, skinfold measurements, weight and height to
health and longevity to aid in interpreting population data; and
dietary intake methodologies that are more easily related to
health and nutritional status. Improved survey methods are also
under study, including the costs and benefits of continuous
surveys and different modus operandi for NHANES. The ultimate
goal of these research initiatives is to increase the usefulness
of the survey data to decision makers at the Federal, State and
local levels.
Do you plan additional subpopulation surveys following the
Hispanic HANES?
Answer: Additional subpopulation surveys similar to Hispanic
HANES are not planned for the immediate future; NHANES III is
now the top priority. As part of the planning for NHANES III,
we are considering alternative methods of obtaining desired
health and nutritional status information on special population
groups, e.g., the poor, the elderly, racial or ethnic
minorities. In NHANES III and future national surveys, one
approach being given serious consideration is to oversample
special population groups. The groups would be selected based
on the needs of data users.
Human Nutrition Research and Information Management System
a. How will DHHS use this system to plan research priorities for budget requests and to manage programs within each fiscal year?
Answer: The Human Nutrition Research Information Management
System (HNRIM) will establish a focus for information on all
projects in human nutrition research funded by the Federal
Government. This focus will enable for the first time a global
view of all Federal efforts in human nutrition research and
therefore help to plan and establish research priorities and to
manage nutrition programs. The system will facilitate the
identification of agency responsibility in human nutrition
research; the identification of the progress made in human
nutrition research; the development of joint program
announcements (PAs), requests for applications (RFAs), and
requests for proposals (RFPs) in areas of nutrition research
that require emphasis; and the development of joint funding
mechanisms. In addition, the HNRIM system will make it possible
for investigators to ascertain which investigators are working
on problems relevant to their work, thus facilitating
communication among scientists working in Federal laboratories,
academia, and industry. The development of a plan for human
nutrition research within the Federal Government will encourage
new investigators to enter the field of nutrition research and
thus increase the number of meritorious applications. After the
system has been operational for a number of years, it will
permit the review of trends in human nutrition research which
will further enhance future planning of research activities.
This kind of review has not been possible in the past due to the
lack of a consistent data base of federally-supported nutrition
research activities.
3. Research, Priorities, Funding and Mission
Last June, the Department indicated a review of the NAS Diet, Nutrition, and Cancer report was under way and the review could be used to guide relevant research prior to receiving the June 1983 supplement on Directions for Research. How was the review integrated into DHHS research planning activities for FY 84 and FY 85?
Answer: During FY 82 and FY 83, the National Cancer Institute
(NCI) developed research plans in the area of diet, nutrition
and cancer and in the area of chemoprevention. These research
plans were developed by NCI staff with imput from the scientific
community and were reviewed by NCI advisory boards in the spring
of 1983. The NAS Diet, Nutrition, and Cancer report of 1982 was
one of several sources used by the NCI staff in its planning
process. The NAS report was of value in determining priorities,
specifically in assigning high priority to the areas of dietary
fat and dietary vitamin A. These priorities are reflected in
the research planning activities for FY 83 - FY 85. In FY 84,
NCI will initiate two clinical trials of low fat diets aimed at
reducing the incidence of breast cancer and at improving the
prognosis of patients with breast cancer. In FY 85 these two
studies will move from a feasibility stage to full scale
implementation. Also in FY 84, NCI will sponsor studies of
modification of eating behavior with particular emphasis on
reducing dietary fat.
By the end of FY 83, NCI will be sponsoring seventeen clinical trials in chemoprevention and fourteen of these will be studying a form of vitamin A. The forms of vitamin A being studied include the provitamin (betacarotene), various forms of the natural vitamin, and various synthetic analogues. This area of research will be expanded in FY 84 and FY 85 with particular emphasis on development of synthetic analogues of vitamin A which have greater efficacy and/or less toxicity. The expanded research will include evaluation of selected agents in animal models, animal toxicology and safety determinations, Phase I clinical studies and Phase III clinical trials.
b. What Department-wide planning mechanisms are used to determine human nutrition research priorities and to allocate funds among NIH, CDC and other agencies such as FDA?
Answer: Several mechanisms are operative to facilitate the determination of human nutrition research priorities. An NIH
Coordinating Committee on Nutrition Activities operates out of
the Office of the Director at the National Institutes of
Health. Discussions growing out of the meetings of that
Committee help to identify and advance research priorities.
the departmental level, information exchanged at the bi-monthly
meetings of the departmental Nutrition Policy Board (for which
the NIH Committee acts as the standing Subcommittee on Nutrition
Research) further promotes discussion of nutrition research
priorities. In addition, ad hoc reviews, such as the
departmental task force established to review the NAS Report on
Diet, Nutrition, and Cancer, help to identify priorities of
importance to the various agencies and institutes. Plans are
also under way to initiate in the coming year a formal and
comprehensive review of nutrition research activities under the
auspices of the newly established Interagency Committee on Human
Nutrition Research.
How does the Bureau of Foods obtain its applied and basic research needs on which to base regulatory decisions? Are the Bureau's research needs submitted to other agencies in DHHS for consideration in Department research planning and budget proposals?
Answer: The breadth of research required by the Bureau of Foods
is large. The research needs continue to evolve commensurate
with knowledge and technological advancement and a continuously
changing food supply. The Bureau developed a research plan in
1980 which defines areas in which increased research efforts are
required to resolve public health issues associated with the
food supply. This document has been made widely available to
other institutions to be used when planning research. The
Bureau endeavors to utilize relevant knowledge developed by
other institutions, both public and private. Collaborative
efforts with other institutions in the planning and conduct of
needed research, particularly the U.S. Department of
Agriculture, greatly enhances the ability of the FDA to perform
its regulatory mission. The FDA nutrition program is dependent
upon the basic biomedical research output of NIH activities, the
nutrition and dietary status evaluations of the National Center
for Health Statistics, the food consumption surveys of USDA, and
the National Nutrient Data Bank of USDA. Contemporary science
is highly specialized and no single institution can perform all
of the research. Consequently, the Bureau maintains an
intramural research program that is augmented with a modest
extramural program to address some of the high priority issues.
Does the Bureau of Foods conduct research to determine the
underlying causes of complications resulting from products which
it regulates, such as the liquid protein diet products? Who
does, or should, conduct such research? Should this be the
responsibility of the Federal Government or the private sector?
Answer: The Food and Drug Administration, as the principal agency responsible for disease prevention and health promotion as they pertain to our food supply, carries out nutrition research of great importance to all Americans. The FDA conducts research required in support of its Food, Drug, and Cosmetic Act mission to ensure the safety, quality and labeling of foods. Its principal mission is to maintain the safety and quality of our nation's food supply. This encompasses activities designed to assure that the nutritional quality of foods is maintained activities such as the food fortification program which ensures that the fortification processes used by industry are conducted in a manner conducive to the maintenance of the nutritional safety and quality of foods. The Agency does conduct very important nutrition research to assure nutritional quality. In addition, FDA is charged with the regulatory responsibility for assuring the safety of food additives and other food ingredients. Of particular importance, FDA conducts studies to assess the impact on human nutrition of technological developments, changes, and marketing practices in the food industry. Often FDA is faced with the need to respond quickly to health emergencies such as the liquid protein diet tragedy that occurred during 1977 and 1973. Although FDA is concerned with real-life problems in the area of nutrition affecting the national health, the research it must undertake frequently requires the acquisition of basic biological information, without which an understanding of the mechanism that underlies a given problem would be impossible. Other public and private institutions have conducted research to enhance basic biological understanding and to determine the underlying causes of complications resultant from foods regulated by FDA. As an example, NIH is currently investigating children who presented with hypochloremic metabolic alkalosis from the consumption of an infant formula that contained an insufficient quantity of chloride. However, other institutions cannot be expected to perform the necessary research on all such problems identified in the food supply and industry is most likely to address only those problems that have direct economic ramifications.
The responsibility pertaining to the safety of food additives and color additives is clearly defined. FDA, under the authority provided by the Food, Drug, and Cosmetic Act requires data that demonstrate the safety of food additives and color additives prior to their approval. The sponsor of such research is usually the industry. Much of this research is conducted by academia and foundations with funds provided by industry or it may be conducted by industry.
What is the role of FDA in monitoring or regulating
vitamin/mineral supplements?
Answer: Vitamin and mineral supplements are regulated in
accordance with the Food, Drug and Cosmetic Act. Some
supplements are regulated as drugs while other supplements are
foods. Those supplements represented for therapeutic uses are
drugs. However, the vast majority of supplements currently
being sold are foods. According to the law, the upper limits of
such supplements, except those for children and pregnant or
lactating women, cannot be regulated based on modern knowledge
of nutrient requirements. These products can only be regulated
on the basis of safety. Safety concerns arise from two
factors. One is the paucity of knowledge of human toxicity.
Secondly, the consumption of supplements has been increasing
rapidly during recent years and is contributing to intakes
considerably in excess of physiological needs. The FDA has just
completed a national survey to determine the prevalence of
supplement uses. This survey will also provide estimates of the
amounts of each vitamin and/or mineral being consumed.
The Private Sector Task Force recommended the transfer of some of the USDA Human Nutrition Research Centers to DHHS because the Centers were conducting clinical research which was outside the mission of USDA. What is your view of the clinical nature of USDA research and what benefits, if any, would be realized by the recommended transfer?
Answer: The USDA Centers on Human Nutrition Research complement
the research supported by NIH. The Centers at Baylor and Tufts
Universities have special interagency agreements with NICHD and
NIA, respectively, because their nutrition research programs are
related. The USDA Centers concentrate on research on the
nutritional requirements of healthy persons. Since some of this
research needs to be carried out in a clinical setting,
collaborative mechanisms have been arranged. Since the
establishment of the Centers, a satisfactory collaborating
mechanism has developed between USDA and the NIH and has
expanded the scientific basis of nutrition research. If in the
future the USDA Centers need to concentrate their research more
in clinical areas a reassessment can be undertaken. But at
present there is no need for change.
Joint Subcommittee on Human Nutrition Research
Did you consult member agencies of the JSHNR, other than USDA, prior to recommending its termination to Dr. Keyworth? Did you consult the Directors of the Bureau of Foods and the Clinical Nutrition Research Units, or the Chairman of the Committee on Health and Medicine of the Federal Coordinating Council for Science, Engineering and Technology? What were their
Our recommendation to transfer responsibilities of the JSHNR to the departmental level was based on our respective consultations within our own Departments, on the management and scientific issues involved. For HHS those consultations included representatives from the National Institutes of Health, the Food and Drug Administration and members of our departmental Nutrition Policy Board. We feel confident that the newly established Interagency Committee on Human Nutrition Research will work effectively to extend the progress of Federal commitment to human nutrition research activities.
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