Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components; and Requirements for Donor Testing, Donor Notification, and "Lookback"

Forms and Documents

Document Name	Status
0116 SSA CBER GMP and Lookback 2018 Ext.pdf Supporting Statement A	2018-04-17

IC Document Collections

IC ID	Document Title	Status
5725	CGMP for Blood and Blood Components: Reporting Requirements	Modified
215608	Physician Notification	Removed
215607	CGMP for Blood and Blood Components: 3rd Party Disclosures	Modified
215606	Donor Notification	Removed
215605	Recipient or Physician Notification	Removed
215604	Consignee Notification	Removed
215602	Consignee Notification	Removed
215598	Recipient or Physician Notification	Removed
215596	Consignee Notification	Removed
215594	Consignee Notification	Removed
215593	Labeling	Removed
215592	Labeling	Removed
215591	Labeling	Removed
215590	Labeling	Removed
215589	Adverse Reaction Records and Reports	Removed
215586	Records (Medical Emergency)	Removed
215585	Adverse Reaction Records and Reports	Removed
215584	Records	Removed
215583	Records (Notification)	Removed
215582	Records (Notification)	Removed
215581	HCV Recipient Notification	Removed
215580	HIV Recipient Notification	Removed
215578	HCV Consignee Notification	Removed
215577	Records (General)	Removed
215576	HIV Consignee Notification	Removed
215575	Records (General)	Removed
215574	Records (General)	Removed
215573	SOPs	Removed
215572	Records (Donors)	Removed
215571	SOPs	Removed
215570	SOPs	Removed
200671	Approval Request	Removed
187286	CGMP for Blood and Blood Components: Recordkeeping Requirements	Modified

ICR Details

OMB Control No: 0910-0116	ICR Reference No: 201804-0910-014
Status: Historical Active	Previous ICR Reference No: 201503-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components; and Requirements for Donor Testing, Donor Notification, and "Lookback"
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: 04/18/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2021	36 Months From Approved	06/30/2018
Responses	3,109,718	0	3,209,844
Time Burden (Hours)	504,448	0	510,173
Cost Burden (Dollars)	0	0	0

---

Abstract: This information collection supports FDA regulations. Current good manufacturing practice (CGMP) regulations for donor testing, donor notification, and "lookback" provide FDA with information necessary to perform its duty to ensure the safety, purity, and potency of blood and blood components. These requirements establish accountability and traceability in the processing and handling of blood and blood components and enable FDA to perform meaningful inspections and initiate recalls. The recordkeeping requirements serve preventative and remedial purposes. The public health objective in testing human blood donors for evidence of infection due to communicable disease agents and in notifying donors is to prevent the transmission of communicable disease.

---

Authorizing Statute(s): US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug and Cosmetic Act
   US Code: 42 USC 262 Name of Law: Public Health: Regulation of biological products
  

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:
	83 FR 3165	01/23/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 16870	04/17/2018
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Records (General)
Labeling
Consignee Notification
Consignee Notification
Consignee Notification
Consignee Notification
HIV Recipient Notification
Records (General)
Records (General)
HCV Consignee Notification
Records (Notification)
HIV Consignee Notification
Records (Notification)
SOPs
Donor Notification
Records
Adverse Reaction Records and Reports
Adverse Reaction Records and Reports
Labeling
Recipient or Physician Notification
CGMP for Blood and Blood Components: Reporting Requirements
CGMP for Blood and Blood Components: Recordkeeping Requirements
HCV Recipient Notification
Labeling
Labeling
CGMP for Blood and Blood Components: 3rd Party Disclosures
Physician Notification
Records (Donors)
SOPs
Records (Medical Emergency)
Recipient or Physician Notification
Approval Request
SOPs

---

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	3,109,718	3,209,844	0	0	-100,126	0
Annual Time Burden (Hours)	504,448	510,173	0	0	-5,725	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: $1,881,876

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: 04/18/2018

---