Emergency Zika Package IV: Assessment of Contraceptive Use and Needs, Puerto Rico, 2016

Forms and Documents

Document Name	Status
SSB - Emergency Zika IV clean OMB 18MAY2016.docx Supporting Statement B	2016-05-18
SSA - Emergency Zika IV clean.docx Supporting Statement A	2016-05-17
Att. D - IRB Determination.PDF Supplementary Document	2016-05-17
Emergency Request Memo_Zika IV_signed 5 16 2016.pdf Supplementary Document	2016-05-17
Att. A - Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2016-05-17

IC Document Collections

IC ID	Document Title	Status
221550	Contraceptive Assessment Questionnaire	New
221549	Contraceptive Assessment Screen	New

ICR Details

OMB Control No: 0920-1114	ICR Reference No: 201605-0920-008
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 16AKV
Title: Emergency Zika Package IV: Assessment of Contraceptive Use and Needs, Puerto Rico, 2016
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 05/18/2016
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/19/2016
	Date Received in OIRA: 05/18/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2016	6 Months From Approved
Responses	14,500	0	0
Time Burden (Hours)	825	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This is a request for emergency OMB approval of the information collection, “Emergency Zika Package IV: Assessment of Contraceptive Use and Needs, Puerto Rico, 2016.” CDC requests six months of OMB clearance. After review of the available evidence, CDC recently concluded that Zika virus infection during pregnancy is a cause of microcephaly and other brain defects. Given the adverse pregnancy and birth outcomes associated with Zika virus infection during pregnancy, it is more important than ever for women who do not desire pregnancy now to have access to effective contraception. The objective of this assessment is to collect scientifically valid, current information on various aspects of contraceptive use and related reproductive health topics from a representative sample of women of reproductive age throughout Puerto Rico.

Emergency Justfication: This information will provide the Puerto Rican government and CDC’s emergency response team a basis on which to make decisions regarding the distribution of effective contraceptive methods among residents of the island who are in need of contraception, Additionally, the study will help to answer several important questions related to contraceptive use, contraceptive needs, and pregnancy in Puerto Rico that will be useful in order to help minimize the risk of Zika-related birth defects among newborn. Collection of this information is essential to the CDC's mission to protect America from health, safety and security threats, both foreign and in the U.S.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: U.S. 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

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
Contraceptive Assessment Screen	NA
Contraceptive Assessment Questionnaire	NA

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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	14,500	0	0	14,500	0	0
Annual Time Burden (Hours)	825	0	0	825	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: The submission is a New Emergency ICR for assessment of contraceptive use in Puerto Rico in the context of the Zika Virus outbreak.

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Annual Cost to Federal Government: $94,656

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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: 05/18/2016

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