Federal Register / Vol. 65, No. 43 / Friday, March 3, 2000 / Notices 11585 statistics on the health of the U.S. for the Congressionally-mandated to be in the field until 2006. This population. Due to the integration of ‘‘Health US’’ and related publications, clearance is for the fifth full year of data health surveys in the Department of as well as the single most important collection using the Basic Module on Health and Human Services, the NHIS source of statistics to track progress CAPI, and for implementation of the also has become the sampling frame and toward the National Health Promotion second ‘‘Periodic Module’’, which first stage of data collection for other and Disease Prevention Objectives, include additional detail questions on major surveys, including the Medical ‘‘Healthy People 2000.’’ conditions, access to care, disabilities, Expenditure Panel Survey, the National Because of survey integration and and health care utilization. The changes in the health and health care of Survey of Family Growth, and the ‘‘Periodic Module’’ will repeat a similar National Health and Nutrition the U.S. population, demands on the survey conducted in 1992, and will help Examination Survey. By linking to the NHIS have changed and increased, track many of the Health People 2010 NHIS, the analysis potential of these leading to a major redesign of the surveys increases. The NHIS has long annual core questionnaire, or Basic objectives. This data collection, planned been used by government, university, Module, and a redesign of the data for January-December 2001, will result and private researchers to evaluate both collection system from paper in publication of new national estimates general health and specific issues, such questionnaires to computer assisted of health statistics, release of public use as cancer, AIDS, and childhood personal interviews (CAPI). Those micro data files, and a sampling frame immunizations. Journalists use its data redesigned elements were partially for other integrated surveys. The total to inform the general public. It will implemented in 1996 and fully cost to respondents is estimated at continue to be a leading source of data implemented in 1997 and are expected $70,860 for the whole survey.

No. of re- No. of re- Avg. burden Total burden Respondents sponses/re- spondents spondent per response (in hrs.)

Family ...... 42,000 1 0.35 14,700 Sample adult ...... 42,000 1 0.70 29,400 Sample child ...... 18,000 1 0.25 4,500

Total ...... 48,600

Dated: February 28, 2000. additive petition (FAP 0A4708) has proponents and opponents of olestra’s Charles Gollmar, been filed by P&G, Winton Hill approval, as well as by members of the Acting Associate Director for Policy, Technical Center, 6071 Center Hill Ave., FAC. Planning, and Evaluation Centers for Disease Cincinnati, OH 45224. The petition In issuing the olestra final rule, FDA Control and Prevention (CDC). proposes to amend the food additive carefully considered the proper labeling [FR Doc. 00–5132 Filed 3–2–00; 8:45 am] regulations in § 172.867 Olestra (21 CFR for foods containing the additive. This BILLING CODE 4163±18±P 172.867) by removing the requirement issue was also discussed in detail before for the label statement prescribed in the FAC. As noted, olestra is not § 172.867(e). absorbed, and it passes through the DEPARTMENT OF HEALTH AND Olestra is a food additive that is gastrointestinal (GI) tract intact. Data HUMAN SERVICES approved for use in place of fats and oils from clinical studies submitted by P&G Food and Drug Administration in prepackaged ready-to-eat savory in support of its original petition show snacks (§ 172.867). Olestra is not that consumption of olestra with a meal [Docket No. 00F±0792] digested to any appreciable degree in can affect the absorption of certain fat- the human gut and is not absorbed or soluble vitamins and nutrients, which The Procter & Gamble Co.; Filing of metabolized by the body. partition into the olestra. The petitioner Food Additive Petition In the Federal Register of June 23, and FDA agreed that these fat-soluble AGENCY: Food and Drug Administration, 1987 (52 FR 23606), FDA announced vitamins needed to be added to the HHS. that P&G had filed a petition (FAP snacks to compensate for any such ACTION: Notice. 7A3997) proposing that the food effect, and that this addition of vitamins additive regulations be amended to was not equivalent to fortification. SUMMARY: The Food and Drug provide for the safe use of olestra. FDA These data also show that olestra has Administration (FDA) is announcing subsequently published a final rule the potential to cause certain GI effects that the Procter & Gamble Co. (P&G) has approving olestra for use in savory such as abdominal cramping and loose filed a petition proposing that the food snacks(61 FR 3118, January 30, 1996) stools. FDA determined that consumers additive regulations regarding olestra be after completing its evaluation of the needed to know about any potential amended by removing the requirement relevant data and information. Prior to effects of olestra on the GI system. for the label statement. the issuance of the final rule, FDA In view of the record before the FOR FURTHER INFORMATION CONTACT: convened a public meeting of its Food agency, FDA concluded that olestra- Mary D. Ditto, Center for Food Safety Advisory Committee (FAC) on containing products would need to and Applied Nutrition (HFS–206), Food November 14 through 17, 1995, to carry an information statement in order and Drug Administration, 200 C St. SW., undertake a scientific discussion of the for such products to avoid being Washington, DC 20204, 202–418–3102. agency’s evaluation of the safety data in misbranded within the meaning of 21 SUPPLEMENTARY INFORMATION: Under the the petition. As a result of the 4-day U.S.C. 343(a)(1) and 321(n). Therefore, Federal Food, Drug, and Cosmetic Act FAC meeting, a substantial portion of the final rule (§ 172.867(e)) required that (the act) (sec. 409(b)(5) (21 U.S.C. the relevant safety data on olestra was foods containing olestra be labeled with 348(b)(5))), notice is given that a food publicly discussed in detail by both the following statement in a boxed

VerDate 022000 22:36 Mar 02, 2000 Jkt 190000 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\03MRN1.SGM pfrm02 PsN: 03MRN1 11586 Federal Register / Vol. 65, No. 43 / Friday, March 3, 2000 / Notices format: ‘‘This Product Contains Olestra. interested members of the public made by Frito-Lay, Inc., in 1996 and 1999, as Olestra may cause abdominal cramping presentations to the Committee. At the well as a variety of other published and loose stools. Olestra inhibits the meeting, there was considerable scientific references, and various letters absorption of some vitamins and other discussion of the label required by submitted to the agency regarding the nutrients. Vitamins A, D, E, and K have § 172.867(e), with a range of views labeling of olestra-containing snacks. been added.’’ This requirement was expressed. The complete set of The petition also discusses other established under section 409(c)(3) of transcripts of the June 1998 FAC information relevant to the olestra label the act (61 FR 3118, 3160). As such, the meeting is publicly available through which can be found in Docket No. 87F– requirement was immediately effective. FDA’s Internet site at http:// 0179. These include comments received Although immediately effective, FDA www.fda.gov/ohrms/dockets/ac/ in response to the agency’s request for requested comments on the label from cfsan98t.htm#Food Advisory Committee comments on the label statement in the interested persons on such issues as the (choose June 15, 16, and 17). olestra final rule (January 30, 1996), and need for labeling, the adequacy of its Since the June 1998 FAC meeting, reports submitted by CSPI. content, and the agency’s current word P&G as well as other interested parties FDA often receives comments on food choices. have submitted additional information additive petitions, especially those for At the time of olestra’s approval, P&G and analyses of the required label which there is a high level of public informed FDA that the company statement to FDA. The recent interest. Although section 409 of the act intended to conduct certain post- submissions include a report from a establishes no comment period for food marketing studies, which included multi-disciplinary panel assembled by additive petitions, and the agency does establishing a system for monitoring P&G and charged with examining the not solicit comments in notices complaints associated with the scientific evidence, as well as the legal announcing the filing of a food additive ingestion of olestra-containing products and policy precedents, in regard to the petition, it is FDA’s customary practice (passive surveillance), a program of label statement. The panel report also to consider any relevant comments active surveillance, and consumer includes information from the ongoing submitted regarding such petitions. In evaluation studies of the required label passive surveillance, and additional the case of olestra, much of the material statement. Since the approval of olestra consumer perception studies regarding relevant to the label issue raised by the in January 1996, olestra-containing the olestra label. petition was submitted to the agency snacks have been introduced into the On December 2, 1999, P&G submitted since the final rule published, and the marketplace, and P&G has carried out the food additive petition that is the bulk of that material was available and the studies and surveillance it subject of this filing notice; the petition discussed at the June 1998 FAC committed to do. The company also requests that the food additive meeting. Consistent with section 409 of sponsored new clinical studies, which regulations be amended to eliminate the the act, FDA will, as part of the review provide additional data and information requirement for the olestra label of P&G’s petition, fairly evaluate all the on possible GI effects from consuming statement. P&G contends that the weight evidence of record, including relevant olestra-containing snacks in ‘‘real-life’’ of the scientific evidence collected since comments received by the agency that situations. A substantial amount of the 1996 approval establishes that the become part of the record. additional data and information have label statement contains inaccurate The agency has determined under 21 been submitted to FDA since the information and is not understood by CFR 25.32(i) that this action is of a type January 1996 olestra approval. consumers. Accordingly, P&G claims that does not individually or Specifically, the agency has received that the olestra label misleads cumulatively have a significant effect on reports from four studies: An Acute consumers and thus misbrands the the human environment. Therefore, Consumption Study (FAP 0A4708, products on which it appears. P&G also neither an environmental assessment exhibit 1, reference B), a 6-Week asserts that the label statement does not nor an environmental impact statement Consumption Facilitated Ad Lib Study convey material information and, thus, is required. is not authorized under sections (FAP 0A4708, exhibit 1, reference C), a Dated: February 15, 2000. Rechallenge Study (FAP 0A4708, 403(a)(1) and 201(n) of the act (21 U.S.C. Alan M. Rulis, exhibit 1, reference D), and a Stool 343(a)(1) and 321(n)) The material that Composition Study (FAP 0A4708, P&G relies on to support its contentions Director, Office of Premarket Approval, Center for Food Safety and Applied Nutrition. exhibit 1, reference E). P&G has also has been incorporated into its petition, submitted reports and analysis of data FAP 0A4708. Much of that material has [FR Doc. 00–5096 Filed 3–2–00; 8:45 am] collected through passive surveillance, been publicly available since the June BILLING CODE 4160±01±F consumer focus group and perception 1998 FAC meeting. studies, literature reviews on In light of the substantial public DEPARTMENT OF HEALTH AND carotenoids and disease, and an analysis interest in this matter and the previous HUMAN SERVICES of the first year of data collected in the public discussion and comment on the ongoing active surveillance study. In olestra label, FDA has determined that Food and Drug Administration addition, the Center for Science in the it is appropriate to make a copy of FAP Public Interest (CSPI) has submitted 0A4708 available at the agency’s [Docket No. 00D±0785] new data and information regarding Dockets Management Branch, Docket Draft Guidance for Industry; Guidance olestra to the agency. No. 00F–0792. Relevant information Consistent with its responsibilities to incorporated into FAP 0A4708 includes on Medical Device Patient Labeling; monitor the safety of all food additives, copies of various reports and published Availability and as set out in § 172.867(f), FDA studies conducted or sponsored by the AGENCY: Food and Drug Administration, presented the new data and information petitioner, as well as a report produced HHS. concerning olestra, and the agency’s by the multi-disciplinary panel ACTION: Notice. evaluation of such new information, to assembled by P&G to evaluate the label the FAC at a meeting held on June 15 statement. Also referenced in the SUMMARY: The Food and Drug through 17, 1998. At this open public petition are consumer perception Administration (FDA) is announcing the meeting, FDA, P&G, CSPI, and other studies on the olestra label conducted availability of a draft guidance entitled

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