Organ Procurement and Transplantation Network Application Form

Forms and Documents

Document Name	Status
Form 17 OPTN Individual Membership Application Form and Instruction	Modified
Form 16 OPTN Business Membership Application Form and Instruction	Modified
Form 15 OPTN Public Organization Membership Application Form and Instruction	Modified
Form 14 OPTN Medical Scientific Membership Application Form and Instruction	Modified
Form G G Change in OPO Key Personnel Form and Instruction	Removed
Form F F Change in Histocompatibility Lab Director Form and Instruction	Removed
Form 13 OPTN Representative Form Form and Instruction	Modified
Form 12 OPTN Membership Application for Histocompatibility Labs Form and Instruction	Modified
Form 11 OPTN Membership Application for OPOs Form and Instruction	Modified
Form 10 OPTN Membership Application for Intestine Transplant Programs Form and Instruction	Modified
Form B16 a B VCA Other Designated Program Application Form and Instruction	Removed
Form B12 B VCA Abdominal Wall Designated Program Application Form and Instruction	Removed
Form 2 OPTN Certificate of Assessment and Program Coverage Plan Membership Application Form and Instruction	Modified
Form B10 B VCA Head and Neck Designated Program Application Form and Instruction	Removed
Form 9 OPTN Membership Application for Vascularized Composite Allograft (VCA) Transplant Program Application Form and Instruction	Modified
Form 8 OPTN Membership Application Islet Transplant Program Form and Instruction	Modified
Form 7 OPTN Membership Application for Lung Transplant Program Form and Instruction	Modified
Form 6 OPTN Membership Application for Heart Transplant Program Form and Instruction	Modified
Form 5 OPTN Membership Application for Pancreas Transplant Programs Form and Instruction	Modified
Form 4 OPTN Membership Application for Liver Transplant Progrms Form and Instruction	Modified
Form 3 OPTN Membership Application for Kidney Transplant Programs Form and Instruction	Modified
Form 1 OPTN Membership Application for Transplant Hospitals Form and Instruction	Modified
FINAL Supporting Statement - 0915-0184.docx Supporting Statement A	2020-06-26
60-Day OPTN FRN OMB No. 0915-0184.Published.pdf Supplementary Document	2020-06-26
Names_Crosswalk.xlsx Supplementary Document	2020-06-26
05.19.2020 Summary of Changes - OPTN 0915-0184.docx Supplementary Document	2020-06-26

IC Document Collections

IC ID	Document Title	Status
226701	OPTN Individual Membership Application Form and Instruction	Modified
226700	OPTN Business Membership Application Form and Instruction	Modified
226699	OPTN Public Organization Membership Application Form and Instruction	Modified
226698	OPTN Medical Scientific Membership Application Form and Instruction	Modified
226697	G Change in OPO Key Personnel Form and Instruction	Removed
226696	F Change in Histocompatibility Lab Director Form and Instruction	Removed
226695	OPTN Representative Form Form and Instruction	Modified
226694	OPTN Membership Application for Histocompatibility Labs Form and Instruction	Modified
226693	OPTN Membership Application for OPOs Form and Instruction	Modified
226692	OPTN Membership Application for Intestine Transplant Programs Form and Instruction	Modified
226691	B VCA Other Designated Program Application Form and Instruction	Removed
226690	B VCA Abdominal Wall Designated Program Application Form and Instruction	Removed
226689	OPTN Certificate of Assessment and Program Coverage Plan Membership Application Form and Instruction	Modified
226688	B VCA Head and Neck Designated Program Application Form and Instruction	Removed
226687	OPTN Membership Application for Vascularized Composite Allograft (VCA) Transplant Program Application Form and Instruction	Modified
226686	OPTN Membership Application Islet Transplant Program Form and Instruction	Modified
226685	OPTN Membership Application for Lung Transplant Program Form and Instruction	Modified
226684	OPTN Membership Application for Heart Transplant Program Form and Instruction	Modified
226683	OPTN Membership Application for Pancreas Transplant Programs Form and Instruction	Modified
226682	OPTN Membership Application for Liver Transplant Progrms Form and Instruction	Modified
226681	OPTN Membership Application for Kidney Transplant Programs Form and Instruction	Modified
226680	OPTN Membership Application for Transplant Hospitals Form and Instruction	Modified

ICR Details

OMB Control No: 0915-0184	ICR Reference No: 202006-0915-007
Status: Active	Previous ICR Reference No: 201906-0915-004
Agency/Subagency: HHS/HSA	Agency Tracking No: 21566
Title: Organ Procurement and Transplantation Network Application Form
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: 08/20/2020
	Date Received in OIRA: 06/29/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2023	36 Months From Approved	08/31/2020
Responses	1,661	0	1,868
Time Burden (Hours)	4,755	0	7,020
Cost Burden (Dollars)	0	0	0

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Abstract: This is a request for OMB approval for revisions of the application documents used to collect information for determining if the interested party is compliant with membership requirements contained in the final rule Governing the Operation of the Organ Procurement and Transplantation Network (OPTN), (42 CFR part 121) ‘‘the OPTN final rule.’’ Respondents include: hospitals seeking to perform organ transplants, non-profit organizations seeking to become an organ procurement organization, and medical laboratories seeking to become an OPTN-approved histocompatibility laboratory.

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Authorizing Statute(s): US Code: 42 USC 273 Name of Law: National Organ Transplant Act of 1984
   US Code: 42 USC 1138 Name of Law: Hospital Protocols for Organ Procurement and Standards for Organ Procurement Agencies
  

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:
	85 FR 8300	02/13/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 38380	06/26/2020
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 17

IC Title	Form No.	Form Name
OPTN Certificate of Assessment and Program Coverage Plan Membership Application	2	Membership_CertificateAssessment_ProgramCoverage Form.docx
G Change in OPO Key Personnel	G	G_OPO_DirectorChange_final_clean_HRSA.doc
F Change in Histocompatibility Lab Director	F	F_HistoLab_PersonnelChange_Clean_HRSA.doc
OPTN Membership Application for OPOs	11	Membership_OPO Form.docx
OPTN Representative Form	13	Membership_Representative Form.docx
B VCA Abdominal Wall Designated Program Application	B12, B13, B14, B15	B12 VCA_AW_Kidney_Updated.doc ,   B13 VCA_AW_Liver_Updated.doc ,   B14 _VCA_AW_Pancreas_Updated.doc ,   B15 VCA_AW_Intestine_Updated.doc
B VCA Head and Neck Designated Program Application	B10	B VCA_Head and Neck_Updated.doc
OPTN Membership Application for Intestine Transplant Programs	10, 10B	Membership_Intestine Form.docx ,   Membership_SurgeonOrPhysicianLog Form.docx
OPTN Membership Application for Histocompatibility Labs	12	Membership_HistoLab Form.docx
OPTN Public Organization Membership Application	15	Membership_PublicOrg Form.docx
OPTN Membership Application for Heart Transplant Program	6B, 6	Membership_Heart Form.docx ,   Membership_SurgeonOrPhysicianLog Form.docx
OPTN Membership Application for Vascularized Composite Allograft (VCA) Transplant Program Application	9, 9B	Membership_VCA Form.docx ,   Membership_SurgeonOrPhysicianLog Form.docx
OPTN Medical Scientific Membership Application	14	Membership_MedicalScientific Form.docx
OPTN Business Membership Application	16	Membership_Business Form.docx
OPTN Individual Membership Application	17	Membership_Individual Form.docx
OPTN Membership Application for Kidney Transplant Programs	3 , 3B	Membership_Kidney_LDKidney Form.docx ,   Membership_SurgeonOrPhysicianLog Form.docx
OPTN Membership Application for Liver Transplant Progrms	4B, 4	Membership_Liver_LDLiver Form.docx ,   Membership_SurgeonOrPhysicianLog Form.docx
OPTN Membership Application for Pancreas Transplant Programs	5, 5B	Membership_Pancreas Form.docx ,   Membership_SurgeonOrPhysicianLog Form.docx
OPTN Membership Application for Transplant Hospitals	1	Membership_Transplant Hospital_General Form.docx
OPTN Membership Application for Lung Transplant Program	7B, 7	Membership_Lung Form.docx ,   Membership_SurgeonOrPhysicianLog Form.docx
OPTN Membership Application Islet Transplant Program	8, 8B	Membership_Pancreas Islet Form.docx ,   Membership_SurgeonOrPhysicianLog Form.docx
B VCA Other Designated Program Application	B16 c, B16 a, B16 b	B16 a VCA_Other_Updated.doc ,   B16 b VCA_Other_NewTransplantProgram_Cover_HRSA.doc_.doc ,   B16 c VCA_Other_PersonnelChange_Cover_HRSA.doc_.doc

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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	1,661	1,868	0	-207	0	0
Annual Time Burden (Hours)	4,755	7,020	0	-2,265	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: Changing Forms

Short Statement: Burden decrease due to less forms and less average burden per response; burden increase due to an increase in respondents.

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Annual Cost to Federal Government: $345,000

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? No

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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: 06/29/2020

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