Longitudinal Investigation of Fertility and the Environment

Forms and Documents

Document Name	Status
Form 1b Female/screening instrument Form and Instruction	Modified
Form 1.o Urine specimen Form and Instruction	New
Form 1.n Blood specimen Form and Instruction	New
Form 1.m Pregnancy test Form and Instruction	New
Form 1.l Fertility monitor Form and Instruction	New
Form 1k Semen specimen Form and Instruction	New
Form 1j High fertility saliva sample Form and Instruction	New
Form 1i Baseline saliva sample Form and Instruction	New
Form 1h Pregnancy journal Form and Instruction	New
Form 1g Male time to pregnancy journal Form and Instruction	New
Form 1f Female time to pregnancy journal Form and Instruction	New
Form 1e Male/baseline questionnaire Form and Instruction	New
Form 1c Male/screening instrument Form and Instruction	New
Form 1.d Female/baseline questionnaire Form and Instruction	New
LIFE Study Supporting Statement Part B _3_25_08_.pdf Supporting Statement B	2008-03-25
Attachment 1.a. Data Collection Schedule.pdf Supplementary Document	2008-03-26
4.d. Illustrations of Data Collection Devices.pdf Supplementary Document	2008-03-26
Attachment 4.b. Summary of Published Prospective Pregnancy Studies with Preconception Enrollment.pdf Supplementary Document	2008-03-26
Attachment 4.a. Listing of Testing, Analytes & Metals to be Measured by Matrix and Required Volume.pdf Supplementary Document	2008-03-26
Attachment 2.b. Study Brochure.pdf Supplementary Document	2008-03-26
Attachment 2.a. Example Letter of Introduction.pdf Supplementary Document	2008-03-26
Attachment 2.c. Informed Consent Document (Texas).pdf Supplementary Document	2008-03-26
Attachment 4.c. Summary of Public Comments and Response by the NICHD.pdf Supplementary Document	2008-03-26
Attachment 2.c. Informed Consent Documents (Michigan).pdf Supplementary Document	2008-03-26
Attachment 3_Texas_IRB.pdf Supplementary Document	2008-03-25
Attachment 3_Texas_Reliance.pdf Supplementary Document	2008-03-25
Attachment 3_RTI_Reliance.pdf Supplementary Document	2008-03-25
Attachment 3_RTI_IRB.pdf Supplementary Document	2008-03-25
Attachment 3_EMMES_IRB.pdf Supplementary Document	2008-03-25
LIFE Study Supporting Statement Part A _3_25_08_.pdf Supporting Statement A	2008-03-25

IC Document Collections

IC ID	Document Title	Status
7467	Female/screening instrument Form and Instruction	Modified
184318	Urine specimen Form and Instruction	New
184317	Blood specimen Form and Instruction	New
184316	Pregnancy test Form and Instruction	New
184315	Fertility monitor Form and Instruction	New
184314	Semen specimen Form and Instruction	New
184313	High fertility saliva sample Form and Instruction	New
184312	Baseline saliva sample Form and Instruction	New
184311	Pregnancy journal Form and Instruction	New
184310	Male time to pregnancy journal Form and Instruction	New
184309	Female time to pregnancy journal Form and Instruction	New
184308	Male/baseline questionnaire Form and Instruction	New
184307	Male/screening instrument Form and Instruction	New
184306	Female/baseline questionnaire Form and Instruction	New

ICR Details

OMB Control No: 0925-0543	ICR Reference No: 200803-0925-006
Status: Historical Active	Previous ICR Reference No: 200610-0925-004
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Longitudinal Investigation of Fertility and the Environment
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/01/2008
	Date Received in OIRA: 03/31/2008
Terms of Clearance: OMB understands that there are no new forms, no changes of any kind to the study protocol. Burden is essentially reduced as NIH is now targeting 500 not 800 couples. The study currently has 430 couples. NIH is just requesting a few additional months to make up for Hurricane Rita and the floods that temporarily closed down the Texas site.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2009	06/30/2010	06/30/2008
Responses	7,000	0	1,000
Time Burden (Hours)	1,110	0	15,380
Cost Burden (Dollars)	0	0	0

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Abstract: Consistent with the NICHD's mission, this cohort study comprising couples desiring pregnancy will assess the relation between persistent environmental agents and lifestyle factors suspected of being reproductive and developmental toxicants.

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Authorizing Statute(s): US Code: 42 USC 285g 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:
	73 FR 2925	01/16/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 15162	03/21/2008
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 14

IC Title	Form No.	Form Name
Female/baseline questionnaire	1.d	Survey
Male/screening instrument	1c	Survey
Male/baseline questionnaire	1e	Survey
Female time to pregnancy journal	1f	Survey
Male time to pregnancy journal	1g	Survey
Pregnancy journal	1h	Survey
Female/screening instrument	1b	Survey
Baseline saliva sample	1i	Survey
High fertility saliva sample	1j	Survey
Semen specimen	1k	Survey
Fertility monitor	1.l	Survey
Pregnancy test	1.m	Survey
Blood specimen	1.n	Survey
Urine specimen	1.o	Survey

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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	7,000	1,000	0	6,000	0	0
Annual Time Burden (Hours)	1,110	15,380	0	-14,270	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This is a revision of a currently approved collection. Fewer respondents are needed to complete the study.

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Annual Cost to Federal Government: $3,811,192

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 03/31/2008

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