Current Good Manufacturing Practices for Finished Pharmaceuticals and Medical Gases

Forms and Documents

Document Name	Status
0139 SSA Finished Pharmaceuticals 2018 Ext.pdf Supporting Statement A	2018-04-16

IC Document Collections

IC ID	Document Title	Status
37604	Recordkeeping CGMP for Finished Pharmaceuticals	Modified
215482	Returned Drug Products	Removed
215481	Compliant Files	Removed
215480	Distribution Records	Removed
215479	Laboratory Records	Removed
215478	Discrepancies in Drug Product Production and Control Records	Removed
215477	Batch Production and Control Records	Removed
215476	Master Production and Control Records	Removed
215475	Component, Drug, Product Container, Closure, and Labeling Records	Removed
215474	Equipment Cleaning and Use Log	Removed
215473	Procedures for Notification of Regulatory Actions	Removed
215472	Production, Control, and Distribution Records	Removed
215471	Laboratory Animals	Removed
215470	Stability Testing	Removed
215469	Test Methodology	Removed
215468	Laboratory Controls	Removed
215467	Expiration Dating	Removed
215466	Tamper-Evident Packaging	Removed
215465	Tamper Evident-Packaging	Removed
215464	Labeling and Packaging Facilities	Removed
215463	Labeling and Packaging Material	Removed
215462	Equipment Identification	Removed
215461	Production and Process Controls	Removed
215460	Components and Drug Product Containers or Closures	Removed
215459	Filters	Removed
215458	Computer or Related Systems	Removed
215457	Automatic, Mechanical, and Electronic Equipment	Removed
215456	Changes in Master Production and Control Records or Other Records	Removed
215455	Equipment Cleaning and Maintenance	Removed
215454	Consultants	Removed
215453	Recordkeeping CGMP for Medical Gases, Containers, and Closures Other-Agency Guidance	Modified

ICR Details

OMB Control No: 0910-0139	ICR Reference No: 201804-0910-009
Status: Active	Previous ICR Reference No: 201502-0910-014
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Current Good Manufacturing Practices for Finished Pharmaceuticals and Medical Gases
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/25/2018
	Date Received in OIRA: 04/16/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2021	36 Months From Approved	06/30/2018
Responses	1,620,586	0	1,301,095
Time Burden (Hours)	1,051,808	0	882,203
Cost Burden (Dollars)	0	0	0

---

Abstract: This information collection supports FDA regulations for finished pharmaceuticals, as well as medical gas containers and closures. The regulations mandate recordkeeping responsibilities that ensure covered articles are produced in accordance with current good manufacturing practice (CGMP). Products not in compliance with CGMP may be deemed adulterated and subject to agency enforcement action.

---

Authorizing Statute(s): US Code: 21 USC 374 Name of Law: FD&C Act
   US Code: 21 USC 331(f) Name of Law: Federal Food, Drug, and Cosmetic Act
  

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 58811	12/14/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 14861	04/06/2018
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Labeling and Packaging Facilities
Tamper Evident-Packaging
Tamper-Evident Packaging
Filters
Equipment Cleaning and Use Log
Test Methodology
Changes in Master Production and Control Records or Other Records
Consultants
Procedures for Notification of Regulatory Actions
Production, Control, and Distribution Records
Recordkeeping CGMP for Finished Pharmaceuticals
Recordkeeping CGMP for Medical Gases, Containers, and Closures
Computer or Related Systems
Equipment Identification
Laboratory Animals
Components and Drug Product Containers or Closures
Production and Process Controls
Automatic, Mechanical, and Electronic Equipment
Laboratory Records
Batch Production and Control Records
Stability Testing
Equipment Cleaning and Maintenance
Master Production and Control Records
Component, Drug, Product Container, Closure, and Labeling Records
Laboratory Controls
Labeling and Packaging Material
Compliant Files
Expiration Dating
Distribution Records
Returned Drug Products
Discrepancies in Drug Product Production and Control Records

---

ICR Summary of Burden

	Total Approved	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	1,620,586	1,301,095	0	0	319,491	0
Annual Time Burden (Hours)	1,051,808	882,203	0	0	169,605	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

---

Annual Cost to Federal Government: $49,525,000

Does this IC contain surveys, censuses, or employ statistical methods? No

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? Uncollected

---

Common Form ICR:  No

---

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: 04/16/2018

---