The rule is expected to bring a modest net social benefit (estimated benefit minus estimated costs) to society. The cost is attributed to the staining of medical gas containers, compliance with the 360° wraparound label requirement for portable cryogenic containers, and the requirement that gas-specific outlet connections on portable cryogenic containers must be permanently attached to the valve body (for example, by silver solder) or attached to the valve body using a locking mechanism or other suitable device so that only the manufacturer removes them easily. or may replace. Using a standard 10-year period, we estimate annualized costs of $180,000 to $1.5 million with a 3% discount rate and between $210,000 and $1.8 million with a 7% discount rate. The benefits are attributed to reducing the likelihood that medical personnel will accidentally administer the wrong gas to patients, resulting in serious injury or death. We estimate that the annualized benefit will range from $800,000 to $2.8 million with a 3% discount rate and between $2.5 million and $8.3 million with a 7% discount rate. Together, we estimate the annualized net benefit between $620,000 and $1.3 million with a discount rate of 3% and between $2.3 million and $6.5 million with a discount rate of 7%. Home Print Page 81687 In addition to the agency`s efforts, the medical gas industry and other organizations have taken steps to prevent confusion with medical gas and ensure the safe use of medical gases. For example, since 1973, the CGA has published a colour coding brochure recommending that certain standard colours be used to identify the contents of medical gas containers. The current (fourth) edition of this standard entitled „CGA C-9–2004 Standard Color Marking of Compressed Gas Containers Intended for Medical Use“ was published on March 10, 2004. Most medical gas manufacturers currently use the colors recommended in the CGA standard to label high-pressure medical gas cylinders so that their contents can be easily identified. Although the stainless steel composition of portable cryogenic containers makes it difficult to apply and maintain paint, manufacturers who fill these containers have also tried to facilitate the identification of gases held in them by other methods.

As discussed in more detail in Sections II.B and IV.B of this document, a large majority of these manufacturers have used 360° wrapping labels in recent years to identify the contents of portable cryogenic containers for medical gases. The CGA recommended the use of these labels in a safety bulletin issued in 2001. [6] For the purposes of proposed Section 211.94(e)(3) and (e)(4) (discussed in the following paragraphs), portable cryogenic medical gas containers include all cryogenic medical gas containers that can both be transported and are intended to be connected to a medical gas supply system in a hospital, health care facility, a nursing home or other facility. or home health care, with the exception of small cryogenic vessels for use by individual patients at home and portable units of liquid oxygen intended to be dispensed empty (i.e. not filled) as described in § 868.5655 (21 CFR 868.5655). The Agency primarily deals with situations where mixtures of medical gases have occurred most frequently (i.e., when a portable cryogenic container containing a gas other than oxygen is delivered and an employee of the gas manufacturer or receiving device incorrectly identifies and is able to do so (by replacing a gas-specific outlet port, that has been removed from an oxygen tank), connecting the inappropriate container to an oxygen supply system for medical purposes). Proposed section 211.94(e)(3) and (e)(4) would not apply to cryogenic containers that are too large (for example, a tanker truck or trailer) to be connected to a medical gas supply system. The FDA proposes that any final rule based on this proposal take effect 60 days after it is published in the Federal Register.

Given that the proposed requirements have already been widely adopted as industry practice, the Agency considers it useful to implement the final Regulation as soon as possible. (v) A portable cryogenic medical gas receptacle may be coloured in the colours referred to in point (c) of this Section only if the gas or gases contained in the receptacle correspond to that colour or colours. Manufacturers have also voluntarily developed gas outlet connectors on portable cryogenic medical gas containers of different threaded dimensions, so these outlet connectors are specific to a particular type of gas and are only compatible with connectors of the supply systems used to supply the particular gas. For these reasons, gas-specific outlet connections on portable cryogenic medical gas containers constitute an obstacle to the misuse of these gases, unless they are removed and replaced or replaced by outlet fittings specific to another type of gas. To ensure that gas outlet fittings on portable cryogenic medical gas containers are not removed, the CGA has issued a safety bulletin recommending that these compounds be welded with silver or attached to the valve body using any other method to prevent removal or that the connection or outlet of the valve body become unusable if removal is attempted or performed. [7] (i) If the container contains only one gas, the name of the gas contained in the container must be printed on the label in one of the following ways: (e) Medical gas containers and closures must meet the following requirements: As set out in section IV.B.1 of this document, the FDA estimates that 90% of the approximately 306,000 portable cryogenic medical gas containers, that would be subject to proposed section 211.94(e)(3) (.9 x 306,000 = 275,400) already meet this proposed provision. The agency therefore expects that approximately 30,600 portable cryogenic containers (306,000 to 275,400) will be brought into compliance with the provision when it is completed. As explained earlier in this document, with respect to these 30,600 containers, the FDA expects manufacturers to choose to use locking devices or other items that would be considered drug container closures to comply with proposed § 211.94(e)(3). As a result, these 30,600 portable cryogenic medical gas containers would be subject to additional registration requirements under § 211.184. As explained earlier in this document, the FDA estimates that an additional time of approximately 2 minutes (2 minutes ÷ 60 minutes per hour = 0.033 hours) per container per year is required to maintain records under § 211.184 for portable cryogenic medical gas containers as a result of proposed § 211.94(e)(3). Therefore, the total additional recording effort resulting from proposed section 211.94(e)(3) would be approximately 1,010 hours from printed page 18052 (30,600 containers x 0.033 hours) per year.

(Answer 1) The FDA partially agrees with these comments and, after a new analysis of the expected costs and expected benefits, has refused to incorporate certain provisions into the proposed rule and has revised other proposed provisions to more effectively achieve public health objectives. Many of the requirements of the final rule are consistent with what we mean by industry practices (ref. 1-3). We continue to believe that medical gas containers and closures, such as portable cryogenic containers and high-pressure cylinders, are an integral part of the drug and play a critical role in ensuring that the drug provided to the patient has the appropriate identity, strength, quality and purity. Therefore, we believe that this rule, as supplemented, is fully consistent with the FDA`s risk-based approach to GMP regulation. Given that valves or locking devices are less expensive than silver soldering and are increasingly used by industry, the FDA expects that companies that do not currently comply with proposed Section 211.94(e)(3) will choose to use these devices to comply with the proposed requirement. Therefore, the cost estimate of the proposed rule includes the locking device option and excludes the silver solder option.

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