Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use - Final Rule

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT 0795 DE FINAL RULE FINAL 6-3-15.doc Supporting Statement A	2015-06-03

IC Document Collections

IC ID	Document Title	Status
216838	Notification of Bacterial Contamination	New
183146	Establish SOPs	Modified
183145	Review and Modify SOPs	Modified
183144	Review and Modify SOPs	Modified
183143	Review and Modify SOPs	Modified
183142	Records (Source Plasma)	Modified
183141	Donor Exceptions	Modified
183140	Donor Eligibility	Modified
183139	Records (General)	Modified
183138	Maintenance of SOPs	Modified
183137	Maintenance of SOPs	Modified

ICR Details

OMB Control No: 0910-0795	ICR Reference No: 201506-0910-006
Status: Historical Active	Previous ICR Reference No: 200712-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use - Final Rule
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: 12/02/2015
	Date Received in OIRA: 06/03/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2018	36 Months From Approved
Responses	42,015,728	0	0
Time Burden (Hours)	7,141,333	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: This information collection requires recordkeeping from establishments that collect blood and blood components and transfusion services to establish and maintain procedures and records for donors and the collection, processing, testing, storage, and distribution of blood and blood components. This information also requires notification to certain blood collection establishments concerning bacterial contamination of platelets. The information collection required by these regulations would be used by the collecting establishment to help ensure that a donor of blood and blood components is free of infectious disease, in good health, and eligible to donate without adversely affecting the health of the donor. In addition, the information collection would be used by the collecting establishment to determine that donations are suitable for transfusion or further manufacture.

---

Authorizing Statute(s): US Code: 42 USC 262 Name of Law: Public Health Service Act
   US Code: 42 USC 264 Name of Law: Public Health Service Act
   US Code: 21 USC 321 Name of Law: Federal Food, Drug, and Cosmetic Act
  

Citations for New Statutory Requirements: Statute at Large: 21 Stat. 606 Name of Statute: null
Statute at Large: 21 Stat. 630 Name of Statute: null
Statute at Large: 21 Stat. 640 Name of Statute: null

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG87	Final or interim final rulemaking	80 FR 29842	05/22/2015

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 11

IC Title	Form No.	Form Name
Maintenance of SOPs
Maintenance of SOPs
Records (General)
Donor Eligibility
Donor Exceptions
Records (Source Plasma)
Review and Modify SOPs
Review and Modify SOPs
Review and Modify SOPs
Establish SOPs
Notification of Bacterial Contamination

---

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	42,015,728	0	3,087,563	38,928,165	0	0
Annual Time Burden (Hours)	7,141,333	0	1,127,850	6,013,483	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: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Changing Regulations

Short Statement: This is a new information collection.

---

Annual Cost to Federal Government: $2,548,800

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

---

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: 06/03/2015

---