Document 2JX5kNqYrej7rMnnKaEJY6ROb

JOSEPH E. KELLER JEROME H HECKMAN CHANGES M MEEHAN WILUAM II. HOROHESANI, JR. ROBERT S.TIEKNAN WAYNE V BLACK DAVID L. HILL MARTIN W. DERCOVICI MARC K. SHAYE X*AW OFFICES Keller and Heckmajst iris N STREET, N. W, WASHINGTON, D.C. 0036 September 1, 1971 TELEPHONE SOS 96-StOO CABLE ADEHESS "SELMAS" All Members of the SPI Food, Drug and Cosmetic Packaging Materials Committee Re: FDA Proposed Rule Making Require Child Protection Packaging Standards for Preparations Containing Aspirin to Gentlemen: As you will recall, we have been keeping you informed, from time to time, relative to develop ments in connection with the Poison Prevention Packaging Act of 1970. Further in this regard we are enclosing herewith a reproduction of page 17512 from the September 1, 1971, Federal Register. As you will note, the Food and Drug Administration has now determined that special packaging, in accordance with the Act, should be required to protect children from ingesting aspirin or preparations containing aspirin. Provision is made for interested persons wishing to file comments to do so within thirty days after publication of this Notice. We would appreciate any comments or instructions members of the Food, Drug and Cosmetic Packaging Materials Committee, or the Food and Drug Bottling Committee of the Plastics Bottle Division might care to give us concerning this proposal. We would anticipate that the manu facturers of the aspirin products would have a more direct interest in commenting in this connection; however, should the members care to submit recommen dations concerning this proposal, please notify us within the next fifteen days, and we shall follow up appropriately. Cordially yours. Enclosure ASI-PR 0001076 Proposed Rule Making DEPARTMENT OF HEALTH. EDUCATION. AND WELFARE Food and Drug Administration I 21 CFR Part 295 J CHILD PROTECTION PACKAGING STANDARDS FOR PREPARATIONS CONTAINING ASPIRIN Proposed Rule Making Through investigations by the Food and Drug Administration and from other available information, the Commissioner of Food and Drugs has determined that the ingestion of aspirin and preparations containing significant amounts of aspirin, have been a leading cause of fatalities and hospitalisations of children under 5 years of age. A review of a 2n>-year compilation (Jan. 1963-June 1970) of Poison Control Center reports received by the National Clearinghouse for Poison Control Centers reveals the following regarding children under 5 years of age; 1. Aspirin is the item most frequently ingested accidentally. 2. Aspudn is the leading cause of hos pitalisations due to accidental poisonings. J. The dosage size of asuirin that is most iitquoTiuy ingested accidentally and that is the leading cause of hos pitalizations is 1 'A grains. 4. Five-grain aspirin is the fourth most frequently ingested accidentally and the sixth leading cause of hospi talizations, 5. Products containing aspirin in com bination with other ingredients have upon accidental ingestion caused fatali ties and hospitalizations. The medical community has long been concerned with aspirin poisoning in chil dren. Tills inspired two FDA confer ences; namely, 1958 Conference on Salic ylate Poisoning and 1966 Conference on Prevention of Accidental Ingestion of Salicylate Products, The first resulted in a warning label and the second in limit ing D/4-grain aspirin tablets to 36 per container. The 1966 conference also con cluded that child-resistant safety clo sures were desirable for packaging 1 In grain aspirin tablets and established a subcommittee on safety closures to de velop methods for evaluating these clo sures, The subcommittee's report specify ing closure testing methodology was submitted to the Commissioner on De cember 7, 1970, After review of the aforementioned in formation and consultation, pursuant to section 3, with the technical advisory committee convened in accordance with section 6 of the Poison Prevention Pack aging Act of 1970, the Commissioner finds that the nature of the hazard to children posed by aspirin and prepara tions containing significant amounts of aspirin, by reason of their availability and packaging, is such that spor i-,U pack aging Li required to protect children from serious personal injury or serious jl'.ne.-,.; resulting from handling, using, or ingest ing such subsuuic.es. Furthermore,' the Commissioner finds that tno .special packaging to be required Is tcchnicaky leasible, practicable and appropimie for such substances. Accordingly, pursuant to provisions of said act (secs. 2(4), 3, 5, 84 5tut. 1679-72; 15 U.S.C. 1471-74), and under authority delegated to him (36 F.R. 11770) the Commissioner proposes to add to Part 295--Regulations Under the Poison Pre vention Packaging Act of 1970 <36 F.R,. 13335), two new sections as follows (other portions of these sections regard ing other substances are being proposed in separate documents): 295.2 Substances requiring "special packaging." (a) The Commissioner has determined that special packaging within the mean ing of section 2(4) of the act and as specified in this part is required to pro tect children from serious personal injury or serious illness and that such packag ing is feasible, practicable, and appropri ate for the following substances; (1) Prescription or nonprescription capsules, tablets, and/or other prepara tions containing aspirin (including "baby aspirin ") shall be packaged in accord ance with the provisions of 5 295.3(a) (1). (b) None of the substances listed under any subparagraph of paragraph (a) of this section shall be distributed in a noncomplymg package under the exemption provided in section 4(a) of the act unless the manufacturer or packer first pro vides the Commissioner of Food and Drugs with a sample of such intended noncomplying package, A sample of each size package of each substance which a manufacturer or packer distributes in "special packaging" shall also be sub mitted. Sample packages should be sent to: Food and Drug Administration, At tention; Bureau of Product Safety, 200 C Street SW,, Washington, D.C. 20204. 295.3 Poison prevention packaging standards. (a) To protect children from serious personal injury or serious illness result ing from handling, using, or ingesting household substances, the Commissioner has determined that packaging designed and constructed to meet the following standards shall be regarded as 'special packaging" within the meaning ot sec tion 2(4) of the act. Specific application of these standards to substances requir ing special packaging is m accordance With } 295.2. (1) Special packaging which when tested by the method described in 295.10 of this part meets the following specifica tions : (1) Child-resistant effectiveness not less than 85 percent without a demon stration and not loss than 80 percent alter a demonstration of the proper means of opening such special packaging. (in Adult-use effectiveness not less than 90 percent. Interested persons may, within 30 days after publication hereof in the Federal Register, file with the Hearing Clerk, Department of Health, Education, and Welfare. Room 6-62, 5600 Fishers Lane, Rockville, lid. 20S52, written comments (preferably in qumtuplicate) regarding this proposal. Comments may be ac companied by a memorandum or brief in support thereof. .Received comments may be seen in the 'above office during regular business hours, Monday through Friday. Dated: August 27,1971. Charles C. Edwards, Commissioner o) Food and Drugs. [FR Doc.71-12781 Filed 8-31-71:8:49 ami DEPARTMENT OF lilrtnOf UtllrillUII Federal Aviation Administration [14 CFR Part 39 ] (Docket No. 11354J BRITTEN NORMAN MODELS BN-2 AND BN-2A AIRPLANES Proposed Airworthiness Directives Tire Federal Aviation Administration Is considering amending Part 39 o'f the Federal Aviation Regulations by adding an airworthiness directive applicable to Britten Norman Models BN-2 and BN2A airplanes. There have been reports of loose Jo-Bolts in the engine frame mounting brackets attached to the wing front spar on models BN-2 and BN-2A airplanes that could result in failure of tire engine frame mounting brackets at tachments. Since this condition is likely Ur exist or develop in other airplanes of the same type design, the proposed air worthiness directive would require peri odic inspection of the six Jo-Bolts se curing each of the two upper engine mounting frame brackets of each engine mounting frame to the wing front spar for security of attachment. Loose Jo- ' Bolts would have to be further inspected lor integrity of locking between the bolt and nut. The directive would also require replacement, with improved attachment bolts in accordance with Britten Norman Modification NB/M/455, of the 12 JoEolts of an engine mounting frame on which the locking between any Jo-Bolt federal register, vol. 36, no. do--Wednesday, September i, 1971 ASI-PR 0001077