COVID-19 Vaccine Screening and Immunization Documentation

Forms and Documents

Document Name	Status
Form 236 Pediatric (5-11 years) COVID-19 Vaccine Screening and Immunization Documentation Form and Instruction	New
Form 207 COVID-19 Vaccine Screening and Immunization Documentation Form and Instruction	Modified
0720-0068_Justification for Change_11.18.2021.docx Justification for No Material/Nonsubstantive Change	2021-11-18
0720-0068_Ref 2_Pfizer 5 though 11 Fact Sheet for Recipients-COVID-19 Vaccine Final.pdf Supplementary Document	2021-11-17
0720-0068_SSA_11.17.2021v3.docx Supporting Statement A	2021-11-17
Reply to HHS comments Covid-19 Screening Docummentation Form 12 Jan.docx Supplementary Document	2021-01-13
IHD Response to CDC comments.pdf Supplementary Document	2021-01-13
Pfizer-BioNTECH COVID-19 Vaccine EUA Fact sheet for Recipients revised 12-23-20.pdf Supplementary Document	2021-01-13
0397469 Coronavirus Disease 2019 Vaccine Guidance (OSD011566-20) eligibility.pdf Supplementary Document	2021-01-13

IC Document Collections

IC ID	Document Title	Status
250385	Pediatric (5-11 years) COVID-19 Vaccine Screening and Immunization Documentation Form and Instruction	New
245326	COVID-19 Vaccine Screening and Immunization Documentation Form and Instruction	Modified

ICR Details

OMB Control No: 0720-0068	ICR Reference No: 202111-0720-001
Status: Received in OIRA	Previous ICR Reference No: 202106-0720-004
Agency/Subagency: DOD/DODOASHA	Agency Tracking No:
Title: COVID-19 Vaccine Screening and Immunization Documentation
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 11/18/2021

	Requested	Previously Approved
Expiration Date	08/31/2024	08/31/2024
Responses	4,616,000	4,000,000
Time Burden (Hours)	153,866	666,667
Cost Burden (Dollars)	4,840,000	4,840,000

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Abstract: The DHA Form 207, “COVID-19 Vaccine Screening and Immunization Documentation” was approved for ages 12 years and older. The Defense Health Agency (DHA) is now seeking approval for DHA Form 236, “Pediatric COVID-19 Vaccine Screening and Immunization Documentation” for those 5-11 years in order to document the clinical determination if the COVID-19 vaccine is appropriate for the specific patient. The COVID-19 Vaccine Working Group and DHA Patient Safety Office recommended a separate form in order to mitigate possible vaccination errors when administering to children ages 5-11.

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Authorizing Statute(s): US Code: 10 USC 55 Name of Law: Medical and Dental Care
  

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:
	86 FR 20130	04/16/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 33691	06/25/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
COVID-19 Vaccine Screening and Immunization Documentation	207	COVID-19 Vaccine Screening and Immunization Documentation
Pediatric (5-11 years) COVID-19 Vaccine Screening and Immunization Documentation	236	Pediatric (5-11 years) COVID-19 Vaccine Screening and Immunization Documentation

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ICR Summary of Burden

	Total Request	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	4,616,000	4,000,000	0	616,000	0	0
Annual Time Burden (Hours)	153,866	666,667	0	-512,801	0	0
Annual Cost Burden (Dollars)	4,840,000	4,840,000	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: Miscellaneous Actions

Short Statement: Respondent burden for DHA Form 207 decreased due to updated estimation of number of the respondents. Added DHA 236, collection in use without an OMB Control Number.

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Annual Cost to Federal Government: $32,290,000

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.     Yes

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.     Yes

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? Yes

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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: 11/18/2021

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