Current Good Manufacturing Practices for Positron Emission Tomography Drugs

Forms and Documents

Document Name	Status
Final_Guidance_Dec_2010.pdf Supplementary Document	2010-09-24
praPETcgmp ss final 12 15 2009.doc Supporting Statement A	2009-12-30

IC Document Collections

IC ID	Document Title	Status
191877	Current Good Manufacturing Practices for Positron Emission Tomography Drugs	New

ICR Details

OMB Control No: 0910-0667	ICR Reference No: 201001-0910-008
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Current Good Manufacturing Practices for Positron Emission Tomography Drugs
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/27/2010
	Date Received in OIRA: 01/28/2010
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved. The agency is reminded that they must submit any collection associated with a rulemaking on or before the date of publication in the final register. This includes both proposed and final rulemakings. Should the agency forget to do so in the future, they may cause unnecessary delay in the implementation of their rule.

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

---

Abstract: FDA is issuing regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drug products. The regulations are intended to ensure that PET drug products meet the requirements of the Federal Food, Drug, and Cosmetic Act (the act) regarding safety, identity, strength, quality, and purity. We are promulgating these CGMP requirements for all PET drugs under the provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act).

---

Authorizing Statute(s): PL: Pub.L. 105 - 105 115 Name of Law: FDAMA
  

Citations for New Statutory Requirements: PL: Pub.L. 105 - 105 115 Name of Law: FDAMA

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AC55	Final or interim final rulemaking	74 FR 65409	12/10/2009

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
Current Good Manufacturing Practices for Positron Emission Tomography Drugs

---

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	101	0	101	0	0	0
Annual Time Burden (Hours)	90,216	0	90,216	0	0	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: This is a new regulation.

---

Annual Cost to Federal Government: $870,000

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]? Uncollected

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: 01/28/2010

---