Population Sciences Biospecimen Catalog (PSBC) (NCI)

Forms and Documents

Document Name	Status
Form 4 Population Sciences Biospecimen Catalog Annual Update Form	New
Form 3 Population Sciences Biospecimen Catalog Annual Update Form	New
Form 2 Population Sciences Biospecimen Catalog Initial Request Form	New
Form 1 Population Sciences Biospecimen Catalog Initial Request Form	New
Supporting Statement A PSBC.docx Supporting Statement A	2015-09-16
Attachment 3. Annual update letter to PIs 050515.docx Supplementary Document	2015-09-15
Attachment 2. letter to PIs 050515.docx Supplementary Document	2015-09-15

IC Document Collections

IC ID	Document Title	Status
218186	Population Sciences Biospecimen Catalog Annual Update Form	New
218185	Population Sciences Biospecimen Catalog Annual Update Form	New
218184	Population Sciences Biospecimen Catalog Initial Request Form	New
218183	Population Sciences Biospecimen Catalog Initial Request Form	New

ICR Details

OMB Control No: 0925-0731	ICR Reference No: 201509-0925-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Population Sciences Biospecimen Catalog (PSBC) (NCI)
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: 02/08/2016
	Date Received in OIRA: 09/16/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2019	36 Months From Approved
Responses	120	0	0
Time Burden (Hours)	80	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This is a request for approval of a new collection. The National Cancer Institute (NCI) Division of Cancer Control and Population Sciences (DCCPS) has previously demonstrated that approximately 60% of population based studies funded by the division use existing biospecimens from other collections, and that those studies are more cost and time efficient than studies collecting new specimens. Yet, it is difficult for researchers to identify potentially appropriate sources for biospecimens and accompanying epidemiologic and exposure data. Development of a searchable inventory of population-based biospecimen resources was a major recommendation resulting from an NCI think tank held in August 2013 ("Utilizing Existing Clinical and Population Biospecimen Resources for Discovery or Validation of Markers for Early Cancer Detection") and would also be directly addressing four of the key recommendations that emerged in an NCI sponsored workshop titled "Trends in 21st Century Epidemiology: From Scientific Discoveries to Population Health" (CEBP, 2013, issue 22, page 508). In response to this, NCI DCCPS is developing a biospecimen inventory and online searchable catalog (or "Population Sciences Biospecimen Catalog (PSBC)"). The PSBC allows scientists in the research community and the NCI to locate specimens appropriate for their population based research projects. It is not NCI's intent to collect biospecimens; rather the collections are descriptions of the available data that can act as a resource and be shared with researchers and scientists who are interested. This submission is via data upload to the secure website in order to collect information to manage and improve a program and its resources for the use by all scientists.

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Authorizing Statute(s): US Code: 42 USC 285 Section 410 Name of Law: Public Health Service Act
  

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:
	80 FR 37280	06/30/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 177	09/14/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Population Sciences Biospecimen Catalog Annual Update	3	Population Sciences Biospecimen Catalog
Population Sciences Biospecimen Catalog Initial Request	2	Population Sciences Biospecimen Catalog
Population Sciences Biospecimen Catalog Initial Request	1	Population Sciences Biospecimen Catalog
Population Sciences Biospecimen Catalog Annual Update	4	Population Sciences Biospecimen Catalog

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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	120	0	0	120	0	0
Annual Time Burden (Hours)	80	0	0	80	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: No

Burden Reduction Due to:

Short Statement: new submission

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Annual Cost to Federal Government: $30,163

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

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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: 09/16/2015

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