Information Collection

CDRH Accreditation Scheme for Conformity Assessment: reporting; recordkeeping; and disclosure elements

IC 240128 under ICR 202212-0910-012 · OMB 0910-0889.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
ASCA-Pilot-Guidance SEPT 2020.pdf	Other-Agency Guidance
ASCA-Pilot-Guidance SEPT 2020.pdf	Other-Agency Guidance
ASCA-Pilot-Biocompatibility-Guidance SEPT 2020.pdf	Other-Agency Guidance
ASCA-Pilot-Biocompatibility-Guidance SEPT 2020.pdf	Other-Agency Guidance
ASCA-Pilot-Standards-Safety-Guidance SEPT 2020.pdf	Other-Agency Guidance
ASCA-Pilot-Standards-Safety-Guidance SEPT 2020.pdf	Other-Agency Guidance
ASCA STR format.pdf	Other-webform
ASCA STR format.pdf	Other-webform
ASCA webform mockups.pdf	Other-webform
ASCA webform mockups.pdf	Other-webform

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

table that charts list of instruments
Document Type	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance	ASCA-Pilot-Guidance SEPT 2020.pdf	Yes	Yes	Fillable Fileable
Other-Agency Guidance	ASCA-Pilot-Biocompatibility-Guidance SEPT 2020.pdf	Yes	Yes	Fillable Fileable
Other-Agency Guidance	ASCA-Pilot-Standards-Safety-Guidance SEPT 2020.pdf	Yes	Yes	Fillable Fileable
Other-webform	ASCA STR format.pdf	Yes	Yes	Fillable Fileable
Other-webform	ASCA webform mockups.pdf	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 158

Number of Respondents for Small Entity: 75

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	2,039	94	1,945
Annual IC Time Burden (Hours)	10,362	-3,129	13,491
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
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.