Survey of Drug Product Manufacturing, Processing, and Packing Facilities

Forms and Documents

Document Name	Status
Supporting Statement Part B - Drug Product Mfg Facilities 2021.docx Supporting Statement B	2021-04-02
Supporting Statement Part A - Drug Product Mfg Facilities 2021.docx Supporting Statement A	2021-04-02

IC Document Collections

IC ID	Document Title	Status
246631	Group 4: Facilities Outside U.S. not engaged in Manufacturing but Engaged in Other Forms of Drug Processing or Packing (e.g., labeling, repacking, etc.) Other-Survey Pre-Notification Link	New
246630	Group 3: Facilities Outside U.S. Engaged in Drug Product Manufacturing (in addition to other possible activites) Other-Survey Pre-Notification Link	New
246629	Group 2: Facilities in U.S. Not Engaged in Manufacturing but Engaged in Other Forms of Drug Processing or Packing (e.g., labeling, repacking, etc.) Other-Pre-Notification Survey Link	New
246628	Group 1: Facilities in U.S. Engaged in Drug Product Manufacturing (in addition to other possible activites) Other-Pre-Notification Survey Link	New

ICR Details

OMB Control No:	ICR Reference No: 202104-0910-002
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Survey of Drug Product Manufacturing, Processing, and Packing Facilities
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 04/07/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	1,395	0
Time Burden (Hours)	1,970	0
Cost Burden (Dollars)	0	0

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Abstract: This ICR collects information on current supply chain risk management practices and manufacturing practices of components in finished pharmaceutical products. The purpose of this survey is to help FDA understand how manufacturers of pharmaceutical products for human and animal use deal with safety and quality issues in their supply chains. This survey will also help FDA understand how practices among manufacturers of drug products may differ due to the different characteristics of the manufactured product(s). The information from this survey will help inform FDA as it develops requirements for good manufacturing practices.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 58370	09/18/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 4098	01/15/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Group 1: Facilities in U.S. Engaged in Drug Product Manufacturing (in addition to other possible activites)
Group 2: Facilities in U.S. Not Engaged in Manufacturing but Engaged in Other Forms of Drug Processing or Packing (e.g., labeling, repacking, etc.)
Group 3: Facilities Outside U.S. Engaged in Drug Product Manufacturing (in addition to other possible activites)
Group 4: Facilities Outside U.S. not engaged in Manufacturing but Engaged in Other Forms of Drug Processing or Packing (e.g., labeling, repacking, etc.)

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	1,395	0	0	1,395	0	0
Annual Time Burden (Hours)	1,970	0	0	1,970	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection.

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Annual Cost to Federal Government: $243,889

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 04/07/2021

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