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 2A 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 1B 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
Attachment D PHSI_April2014_Meeting_Roster.pdf Supplementary Document	2018-08-27
Attachment C 60 day FRN_published.pdf Supplementary Document	2018-08-27
Attachment B Decision Matrix.pdf Supplementary Document	2018-08-27
Attachment A Legislation.pdf Supplementary Document	2018-08-27
FINAL SupportingStatement Part B.docx Supporting Statement B	2018-08-27
FINAL 09060014 SupportingStatement A.docx Supporting Statement A	2018-08-27

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: 201808-0906-002
Status: Active	Previous ICR Reference No: 201502-0906-002
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
OIRA Conclusion Action: Approved with change	Conclusion Date: 11/06/2018
	Date Received in OIRA: 08/28/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2021	36 Months From Approved	11/30/2018
Responses	178	0	178
Time Burden (Hours)	1,300	0	1,300
Cost Burden (Dollars)	0	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): US Code: 42 USC 300b-10 Name of Law: Public Health Service Act, Title XI
   PL: Pub.L. 113 - 240 1111 Name of Law: ewborn Screening Saves Lives Reauthorization Act of 2014
  

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:
	83 FR 26064	06/05/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 42910	08/24/2018
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
INITIAL Survey of the Secretary's Discretionary Advisory Committee on Heritable Disorders in Newborns and Children's Public Health System Assessment	1A, 1B	InitialSurvey_REVISED_TrackedChanges 0014.pdf ,   InitialSurvey_REVISED_Clean0014.docx
FOLLOW-UP Survey of the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children's Public Health System Assessment	2A, 2B	FollowupSurvey_REVISED_Clean 0014.docx ,   FollowupSurvey_REVISED_TrackedChanges 0014.pdf

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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	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? Uncollected

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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: 08/28/2018

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