0338 Non Substantive Change Request

Food and Drug Administration
Non-Substantive Change Request
OMB Control No. 0910-0338

Purpose: FDA is requesting non-substantive change approval of Form FDA 356h, Application
to Market a New or Abbreviated New Drug or Biologic for Human Use, currently approved
under OMB Control No. 0910-0338.
Background: Regulations in 21 CFR Parts 314 (Applications for FDA Approval to Market a
New Drug) and 601 (Biologics/Licensing) govern the submission of new drug applications and
biologics, respectively. FDA’s Center for Drug Evaluation and Research (CDER) and Center for
Biologics Evaluation and Research review these submissions, where the agency has developed
Form FDA 356h to assist respondents in this regard. The application form serves primarily as a
checklist for firms to gather and submit certain information to FDA. As such, the form 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. In addition, the form provides key information to
FDA for efficient handling and distribution to the appropriate staff for review. The form is
available electronically and may be submitted electronically.
Justification: We believe these revisions will facilitate more expeditious processing as they
allow respondents to provide greater specificity regarding the submission. Specifically:
Field 20: language update – added ‘s’ to Drug, Number and Product
Field 24 (new language and design) – ‘Human Factors Information’:

Field 27 & 28: Fields will be removed. Consequent fields will be renumbered.
Field 29 (new field 27): The second portion of field 29, the heading needs to be more specific by
adding the following bolded words: Establishment Contact Information at the site/facility
Field 31 (new field 29, box 18): MDUFMA should read ‘MDUFA.’
Bottom right hand corner of page 2: Item 31 has been updated to Item 29