Information Collection

Biowaiver requests

IC 278264 under ICR 202512-0910-001 · OMB 0910-0032.

Documents and Forms

Document Name Document Type
GFI171.pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-171-demonstrating-bioequivalence-soluble-powder Other-Agency Guidance
GFI171.pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-171-demonstrating-bioequivalence-soluble-powder Other-Agency Guidance

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Biowaiver requests	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			GFI171.pdf	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-171-demonstrating-bioequivalence-soluble-powder-oral-dosage-form-products-and-type-medicated	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 4	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	4	4
Annual IC Time Burden (Hours)	40	40
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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