Current Good Manufacturing Practices for Positron Emission Tomography Drugs

Forms and Documents

Document Name	Status
0667 SS Part A 2016.pdf Supporting Statement A	2016-08-04

IC Document Collections

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

ICR Details

OMB Control No: 0910-0667	ICR Reference No: 201608-0910-007
Status: Historical Active	Previous ICR Reference No: 201307-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
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: 09/21/2016
	Date Received in OIRA: 08/04/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2019	36 Months From Approved	09/30/2016
Responses	807,145	0	694,402
Time Burden (Hours)	132,546	0	147,456
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports recordkeeping requirements under the Current Good Manufacturing Practice regulations for Positron Emission Tomography (PET) drugs. The regulations establish recordkeeping requirements that include: 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. The regulations also require 3rd Party Disclosure requirements regarding specific notices. Respondents to the collection are manufacturers of PET drugs.

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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:
	80 FR 81332	12/29/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 44876	07/11/2016
Did the Agency receive public comments on this ICR? Yes

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

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

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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	807,145	694,402	0	112,743	0	0
Annual Time Burden (Hours)	132,546	147,456	0	-14,910	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Individual ICs have been consolidated where appropriate reducing 17 ICs to 2. This is explained more fully in the agency's supporting statement at Q.15.

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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: 08/04/2016

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