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
Bacterial Risk Control Strategies for Blood Collections Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry.pdf Supplementary Document	2018-12-10
0116 bacterial detection of platelets Nonsub Request Dec 2018.pdf Justification for No Material/Nonsubstantive Change	2018-12-10
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	Unchanged
215607	CGMP for Blood and Blood Components: 3rd Party Disclosures	Unchanged
187286	CGMP for Blood and Blood Components: Recordkeeping Requirements	Unchanged

ICR Details

OMB Control No: 0910-0116	ICR Reference No: 201812-0910-006
Status: Historical Active	Previous ICR Reference No: 201804-0910-014
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: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/31/2019
	Date Received in OIRA: 12/11/2018
Terms of Clearance: Approved with the understanding that any changes to this collection as a result of finalizing the relevant guidance will be submitted for review and approval in a timely manner.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2021	06/30/2021	06/30/2021
Responses	3,109,718	0	3,109,718
Time Burden (Hours)	504,448	0	504,448
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: 42 USC 262 Name of Law: Public Health: Regulation of biological products
   US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug and Cosmetic Act
  

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
CGMP for Blood and Blood Components: Recordkeeping Requirements
CGMP for Blood and Blood Components: 3rd Party Disclosures
CGMP for Blood and Blood Components: Reporting Requirements

---

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	3,109,718	0	0	0	0
Annual Time Burden (Hours)	504,448	504,448	0	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:

---

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: 12/11/2018

---