The Secretary's Discretionary Advisory Committee on Heritable Disorders in Newborns and Children's Public Health System Assessment Surveys

Forms and Documents

Document Name	Status
Form 2 FOLLOW-UP Survey of the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children's Public Health System Assessment Form and Instruction	Modified
Form 1 INITIAL Survey of the Secretary's Discretionary Advisory Committee on Heritable Disorders in Newborns and Children's Public Health System Assessment Form and Instruction	Modified
Decision Matrix_New Logo.pdf Supplementary Document	2021-10-06
Attachment C 60 day FRN ACHDNC OMB No - 0906-0014 - 2021-15598 - 071220215004.pdf Supplementary Document	2021-10-06
Attachment B_USCODE-2018-title42-chap6A-subchapIX-partA-sec300b-10 (5).pdf Supplementary Document	2021-10-06
Attachment A_USCODE-2010-title42-chap6A-subchapI-partA-sec217a.pdf Supplementary Document	2021-10-06
Supporting Statement Part B.docx Supporting Statement B	2021-10-06
Supporting Statement A.docx Supporting Statement A	2021-10-06

IC Document Collections

IC ID	Document Title	Status
215121	FOLLOW-UP Survey of the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children's Public Health System Assessment Form and Instruction	Modified
215120	INITIAL Survey of the Secretary's Discretionary Advisory Committee on Heritable Disorders in Newborns and Children's Public Health System Assessment Form and Instruction	Modified

ICR Details

OMB Control No: 0906-0014	ICR Reference No: 202110-0906-003
Status: Received in OIRA	Previous ICR Reference No: 201808-0906-002
Agency/Subagency: HHS/HRSA	Agency Tracking No:
Title: The Secretary's Discretionary Advisory Committee on Heritable Disorders in Newborns and Children's Public Health System Assessment Surveys
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/19/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	11/30/2021
Responses	178	178
Time Burden (Hours)	1,300	1,300
Cost Burden (Dollars)	0	0

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Abstract: The purpose of the public health system assessment surveys is to inform the Secretary’s Advisory Committee on Heritable Disorders on the ability to add newborn screening for particular conditions within a state, including the feasibility, readiness and overall capacity to screen for a new condition. Data collection surveys will be sent to all state newborn screening programs in the United States.

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Authorizing Statute(s): PL: Pub.L. 113 - 240 1111 Name of Law: ewborn Screening Saves Lives Reauthorization Act of 2014
   US Code: 42 USC 300b-10 Name of Law: Public Health Service Act, Title XI
  

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 38726	07/22/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 57678	10/18/2021
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
FOLLOW-UP Survey of the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children's Public Health System Assessment	2	Followup Survey_CLEAN.docx
INITIAL Survey of the Secretary's Discretionary Advisory Committee on Heritable Disorders in Newborns and Children's Public Health System Assessment	1	Initial Survey_CLEAN.docx

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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	178	178	0	0	0	0
Annual Time Burden (Hours)	1,300	1,300	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:

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Annual Cost to Federal Government: $82,606

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: 10/19/2021

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