Information Collection

Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802

IC 188596 under ICR 200903-0910-006 · OMB 0910-0498.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0498 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form FDA 3613b Supplementary Information Certificate of a Pharmaceutical Product Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802	Form and Instruction
Form FDA 3613a Supplementary Information Certificate of Exportability Requests Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802	Form and Instruction
Form FDA 3613 Supplementary Information Certificate to Foreign Government Requests Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802	Form and Instruction
Form FDA 3613c Supplementary Information Non-Clinical Research Use Only Certificate Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802	Form and Instruction
Form FDA 3613d Office of Cosmetics and Colors "Certificate" Export Application Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802	Form and Instruction
Form FDA 3613e Food Export Certificate Application Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802	Form and Instruction
FDA 3613a Supplementary Information Certificate of Exportability R FDA-3613a.pdf	Form and Instruction
FDA 3613 Supplementary Information Certificate to Foreign Governm FDA-3613.pdf	Form and Instruction
FDA 3613b Supplementary Information Certificate of a Pharmaceutica FDA-3613b.pdf	Form and Instruction
FDA 3613c Supplementary Information Non-Clinical Research Use Only FDA-3613c.pdf	Form and Instruction
FDA 3613d Office of Cosmetics and Colors "Certificate" Export Appl FDA-3613d.pdf	Form and Instruction
FDA 3613e Food Export Certificate Application FDA-3613e.pdf	Form and Instruction

Information Collection (IC) Details

View Information Collection (IC)

IC Title:

Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802

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:

table that charts list of instruments
Document Type	Form No.	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA 3613a	Yes	No	Paper Only
Form and Instruction	FDA 3613	Yes	No	Paper Only
Form and Instruction	FDA 3613b	Yes	No	Paper Only
Form and Instruction	FDA 3613c	Yes	No	Paper Only
Form and Instruction	FDA 3613d	Yes	No	Paper Only
Form and Instruction	FDA 3613e	Yes	No	Paper Only

Federal Enterprise Architecture Business Reference Module

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 6,091

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	6,091	6,091
Annual IC Time Burden (Hours)	12,182	12,182
Annual IC Cost Burden (Dollars)	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.

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