Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation

Forms and Documents

Document Name	Status
0073 ss 11-29-13.doc Supporting Statement A	2013-12-12

IC Document Collections

IC ID	Document Title	Status
5715	Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation	Modified

ICR Details

OMB Control No: 0910-0073	ICR Reference No: 201312-0910-006
Status: Historical Active	Previous ICR Reference No: 201010-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: 21005
Title: Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/07/2014
	Date Received in OIRA: 12/19/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2017	36 Months From Approved	02/28/2014
Responses	25,986	0	8,924
Time Burden (Hours)	9,043,128	0	3,105,552
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information from medical device manufacturers who must meet the Current Good Manufacturing Practice Quality System (CGMP/QS) requirements for purchasing and service controls; recordkeeping requirements for device failure and complaint investigations; requirements for verifying/validating production processes and process or product changes; and requirements for product acceptance activities, quality data evaluations, and corrections of nonconforming product/quality problems. CGMP/QS information collections assist FDA inspections of manufacturer compliance with quality system requirements encompassing design, production, installation, and servicing processes. Manufacturers must ensure that medical devices meet design specifications and that design specifications are effectively transferred from research and development to production.

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Authorizing Statute(s): US Code: 21 USC 371 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 374 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 381 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 384 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 351 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 360 Name of Law: Federal Food, Drug, and Cosmetic Act
  

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:
	78 FR 46347	07/31/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 74146	12/10/2013
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation

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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	25,986	8,924	0	0	17,062	0
Annual Time Burden (Hours)	9,043,128	3,105,552	0	0	5,937,576	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: The estimated annual number of recordkeepers has been adjusted from 8,924 to 25,986. Upon review of the data and this ICR we have determined that, for a more accurate estimate of recordkeepers, it is preferable to estimate the number of recordkeepers based on the number of establishments, rather than the number of owner/operators of those establishments. Additionally, because all registered establishment types must comply with the CGMP/QS regulations, we have included both domestic and foreign establishments in the estimate. A query of the Agency's registration and listing database for fiscal year (FY) 2012 shows that 15,113 domestic and 10,873 foreign establishments are subject to the regulations. Therefore, there are approximately 25,986 recordkeepers. The recalculation of the estimated annual recordkeepers using establishments rather than owner/operators and the inclusion of foreign establishments has resulted in an increase of 5,937,576 hours to the total recordkeeping burden. There has been no change to the existing program, including the respondents subject to the recordkeeping requirements. The adjustment is a result of recalculation of the respondents to more accurately and appropriately include the respondents subject to the requirements.

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Annual Cost to Federal Government: $39,830,080

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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

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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: 12/19/2013

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