Current Good Manufacturing Practices for Positron Emission Tomography Drugs

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT 0667 7-25-13.doc Supporting Statement A	2013-07-25

IC Document Collections

IC ID	Document Title	Status
207965	Sterility Test Failure Notices - 212.70(e)	New
207964	Complaints - 212.100(b) and (c)	New
207963	Complaints - 212.20(c); 212.100(a)	New
207962	Distribution Records - 212.90(b)	New
207961	Distribution Records - 212.20(c); 212.90(a)	New
207960	Reprocessing Procedures - 212.20(c); 212.71(d)	New
207959	Out-of-Specification Investigations - 212.71(b)	New
207958	Out-of-Specification Investigations - 212.20(c); 212.71(a)	New
207957	Conditional Final Releases - 212.70(f)	New
207956	Laboratory Testing Records - 212.60(g); 212.61(b); 212.70(d)(2) and (d)(3)	New
207955	Laboratory Testing Records - 212.20(c); 212.60(a) and (b); 212.61(a); 212.70(a), (b), and (d)	New
207954	Records of Components, Containers, and Closures - 212.40(e)	New
207953	Records of Components, Containers, and Closures - 212.20(c); 212.40(a) and (b)	New
207952	Equipment and Facilities Records - 212.30(b); 212.50(d); 212.60(f)	New
207951	Equipment and Facilities Records - 212.20(c); 212.30(b); 212.50(d); 212.60(f)	New
207950	Batch Production and Control Records - 212.20(d) and (e); 212.50(c); 212.80(c)	New
191877	Batch Production and Control Records - 212.20(c) and (e); 212.50(a) and (b)	Modified

ICR Details

OMB Control No: 0910-0667	ICR Reference No: 201307-0910-007
Status: Historical Active	Previous ICR Reference No: 201001-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: 20139
Title: Current Good Manufacturing Practices for Positron Emission Tomography Drugs
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: 09/16/2013
	Date Received in OIRA: 07/30/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2016	36 Months From Approved	09/30/2013
Responses	694,402	0	101
Time Burden (Hours)	147,456	0	90,216
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection includes the following current good manufacturing practices recordkeeping requirements: Batch Production and Control Records; Equipment and Facilities Records; Records of Components, Containers, and Closures; Process Vertification; Laboratory Testing Records; Sterility Test Failure Notices; Conditional Final Releases; Out-of-Specification Investigations; Reprocessing Procedures; Distribution Records; and Complaints.

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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:
	78 FR 17215	03/20/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 42960	07/18/2013
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 17

IC Title	Form No.	Form Name
Batch Production and Control Records - 212.20(c) and (e); 212.50(a) and (b)
Batch Production and Control Records - 212.20(d) and (e); 212.50(c); 212.80(c)
Equipment and Facilities Records - 212.20(c); 212.30(b); 212.50(d); 212.60(f)
Equipment and Facilities Records - 212.30(b); 212.50(d); 212.60(f)
Records of Components, Containers, and Closures - 212.20(c); 212.40(a) and (b)
Records of Components, Containers, and Closures - 212.40(e)
Laboratory Testing Records - 212.20(c); 212.60(a) and (b); 212.61(a); 212.70(a), (b), and (d)
Laboratory Testing Records - 212.60(g); 212.61(b); 212.70(d)(2) and (d)(3)
Conditional Final Releases - 212.70(f)
Out-of-Specification Investigations - 212.20(c); 212.71(a)
Out-of-Specification Investigations - 212.71(b)
Reprocessing Procedures - 212.20(c); 212.71(d)
Distribution Records - 212.20(c); 212.90(a)
Distribution Records - 212.90(b)
Complaints - 212.20(c); 212.100(a)
Complaints - 212.100(b) and (c)
Sterility Test Failure Notices - 212.70(e)

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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	694,402	101	0	0	694,301	0
Annual Time Burden (Hours)	147,456	90,216	0	0	57,240	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 information collection burden has changed from 90,216 to 147,456 as a result of updated data used by FDA and increases in response to the public comments we received on the 60-day notice.

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Annual Cost to Federal Government: $725,000

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: 07/30/2013

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