Defining Small Number of Animals for Minor Use Determination; Periodic Reassessment
CVM Defining Small Number of Animals for Minor Use Determination Periodic Reassessment OPEN
2022-10-19 2022-10-21 2022-09-19 2022-11-04 2022-10-03
FDA-2022-N-1128-0013 FDA-2022-N-1128-0014 FDA-2022-N-1128-0008 FDA-2022-N-1128-0015 FDA-2022-N-1128-0009
04:00:00 04:00:00 04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/FDA-2022-N-1128-0013 https://api.regulations.gov/v4/comments/FDA-2022-N-1128-0014 https://api.regulations.gov/v4/comments/FDA-2022-N-1128-0008 https://api.regulations.gov/v4/comments/FDA-2022-N-1128-0015 https://api.regulations.gov/v4/comments/FDA-2022-N-1128-0009
Anonymous Vishali Jean Margo Ian
Anonymous Muthuvinayagam Publiee M Epperson
The article discussed the study of testing a small number of animals. The small number was around 80,000 for animal testing. This is considering a small amount due to the amount of testing that has to be done. The world is consciously growing with different products, diseases and etc. It is not safe to conduct on actual people, so animals are being used. I agree with the article keeping the numbers low. However, we cannot determine what is low. We do have to use animal for testings over humans. As long as the numbers are not to extreme with testing, I see no issue on this motion,  The FDAs proposal Defining Small Number of Animals for Minor Use Determination; Periodic Reassessment is an important rule that can incentivize the animal drug industry to seek FDA approval. I agree with a portion of section  D. Costs and Benefits that the proposed rule may help pet owners who need FDA-approved animal drugs for their pets with special needs. Drug development incentives help animal drug testing companies better regulate their medication. This regulation is imperative to the health of animals receiving medication. The clause mentioned for sponsors is extremely efficient in terms of allowing annual renewal and requiring substantial evidence. In response to ways in which the FDA could change the quality, utility and clarity of the information, the absolute definition of what the increased size of animals will be, must be reiterated throughout the proposal. Furthermore, the proposal could benefit from emphasizing this threshold of animals as an adjusted number to define who could qualify for minor drug use. The other comments, although reactionary, have mistaken the small number of animals as a pool to test. This misconception could be further clarified in the beginning of the proposal. Alongside clarification of what the upper-level threshold, there should be a continued effort to say veterinary drugs, thus people will not believe this testing is for human use. Another feature of this proposal that should be amended is the timeline of the reassessment for the threshold. The reassessment of the numbers was conducted in 2018 to 2019. This timeline is before the COVID-19 pandemic, which had an increase in pet adoption and household pets. There should be an exception to the reassessment rule of five years if a known historical spike in pet ownership exists. According to the American Pet Products Association, the number of household pets has increased over 60% since 2019. (APPA, Pet Industry Market Size, 2021). This oversight may lead to another increase in the upper threshold for pets. The Brakke report indicated as well is from 2018, which leaves a gray area to the number of disease incidence that have occured.The annual designation reports to FDA, and the costs of minor use determination requests are explained and executed properly, but there should be more information on the one-time cost to reading and understanding the rule. This one-time cost should be prevalent in the docket as a specified measure. I ask, if the cost will change based on the price of the drug, the means of production for creating a drug, and the profit of an animal drug company. An imperative factor of this proposal I applaud is understanding the cost pet owners are paying for animal medication. The method to allow drug companies to bypass conditional approval and instead roll out new drugs on the basis of substantial evidence will be cost-effective to both the FDA and specific companies. This extra step helps maintain that increasing the threshold and drug production will also be accessible to the consumer. However, if there are many incentives for drug companies to release minor-use drugs quickly, what measures are used to stop drug companies from overpricing their product? How will an animal drug company be monitored from overcharging medication in order to create a greater profit margin? Although I agree strongly with this federal proposal, I believe it is a necessary step to increase the rate of animal drugs that are needed for rare cases. The proposal, however, needs to provide more information and clarify small points for accessibility. The explanation of what a small number of cats and dogs mean could be reaffirmed as to not shock people. More information towards the pet owner and cost protection would be important to add. The references used could benefit from newer journals that reflect the spike in pet ownership since 2020. This proposal should be a part of the regulatory process in order to help thousands of animals.  proposal is for killing 80,000 dogs and l50,000 cats in labs under this proposal. and you have the audacity to call that a smallnumbers. i find that egregious and the actions of mad scientists. a small number is l00 dogs, l00 cats. the usa public wants all use of any animals to be stopped entirely since the fact is the results of using animnals for drugs for humans makes zero sense. so that uwe can use cells and real people to do lab tests for human drugs and once we find out they are safe for humans then we can transfer them carefully to animals. stop this massacre of aninmals now. we need to stop mad crazy scientisst= from using this method developed in l500 a.d. Food and Drug Administration21 CFR Part 516 [Docket No. FDA2022N1128] RIN 0910AI46Defining Small Number of Animals for Minor Use Determination; PeriodicReassessment AGENCY: Food and Drug Administration HHS.ACTION: Proposed rule.I am a concerned citizen of the US. I came across this proposed rule while searching for what was going on with animals in regulatory actions. It is common knowledge that most drugs for Humans are tested on animals first including dogs and cats before they have any kind of human trials as stated on the FDA site. I know from personal experience that animals use many of the same drugs and medicines that Humans do, considering that most drugs are tested on animals first which is not surprising. Your proposed rule is to revise the small number of animals definition for dogs and cats in your existing regulation for new animal drugs for minor use or minor species. For the purpose to provides incentives to encourage animal drug sponsors to develop and seek FDA approval of drugs intended for use in minor animal species or minor uses in major animal species. You want to revise the small number of dogs included in the small number of animals definition from 70,000 to 80,000 and the small number of cats from 120,000 to 150,000. The reasoning behind this is to market drugs earlier, which in turn could benefit pet owners by improving the health of dogs and cats with uncommon diseases or conditions.While I understand the need for some animal testing for both human and animal drugs, 70,000 dogs and 120,000 cats are not a small number. What you are proposing to raise it to does not seem like much, until you want to raise it again in the future.  If the purpose is to develop drugs for uncommon diseases in dogs and cats is not 70,000 and 120,000 not enough? I do not think raising the number would have much of an impact on drug development if it had not already been done so. While you do have the option to revisit this in the future, maybe we should think of ways of lowering the number not raising it. I do believe using that many animals which is not a small number will lead to an inhumane place. This rule seems like this would further the support for minor animals which is beneficial for owners of minor animals so I will support this rule. 