Question

Please summarize the below article in you own words (150 words)

No plagiarism please

Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Using the Form FDA 356h

In the Federal Register of July 8, 1997 (62 FR 36558), FDA announced the availability of the revised Form FDA 356h. The form was revised as a “Reinventing Government” initiative to harmonize application procedures between CBER and CDER. The application form serves primarily as a checklist for firms to gather and submit to the agency studies and data that have been completed. The checklist helps to ensure that the application is complete and contains all the necessary information, so that delays due to lack of information may be eliminated. The form provides key information to the agency for efficient handling and distribution to the appropriate staff for review. For biologics manufacturers, the form will replace a number of different ELA and PLA forms that were formerly used for these products. The information collection burden for various ELA and PLA forms is covered under OMB Control No. 0910-0124. There are an estimated 343 licensed biologics manufacturers. However, not all manufacturers will have any submissions in a given year and some may have multiple submissions. The annual responses are based on submissions received by FDA in 1998. The time estimated to prepare an ELA, PLA, or BLA under § 601.2 for CBER approval to market a new product is based on information provided by industry. The time required for preparing an ELA, PLA, or BLA includes the estimate for filling out the form. The estimated average burden hours for the other submissions using Form 356h to CBER is based on past FDA experience and includes the time to fill out the form and collate the documentation.

Answer 1

FDA announced a revised form of FDA 356h, in the Federal register of July 8,1997 which is a 'Reinventing Government' initiative between CBER and the primary purpose of this is to collect and submit data and agency studies.The checklist make sure that the data is complete before submission to avoid any errors.Besides,this form helps in efficient handling and distribution to right review of staffs.This form also helpshelps the biologic manufacturers in replacing ELA and PLA forms which used before.Out of 343 registered biologic manufacturers, some does not have any submissions whereas some have multiple submissions under OMB control number 0910-0124. The annual submissions depends on responses received by FDA in 1998 and time based on the information by industry.Also the average burden hours depends on the past experiences of FDA.