Form 2.2 Survey

OMB #: 0925-0593

Expiration Date: xx/xxxx

JULY LAUNCH VERSION

VERSION 7/14/2010

Recruitment Strategy Substudy

Low-Intensity CATI Pregnancy Screener

TABLE OF CONTENTS

CATI

VERBAL CONSENT TO SCREENING FOR STUDY ELIGIBILITY

GENERAL ELIGIBILITY QUESTIONS

FAMILIARITY WITH THE NATIONAL CHILDREN’S STUDY

PREGNANCY SCREENER

DEMOGRAPHICS

TRACING QUESTIONS

CLOSING STATEMENTS

CONCLUSION

FINAL INTERVIEWER-COMPLETED QUESTIONS

NOTE: Questionnaire and other required text is shown in regular font. Interviewer instructions and text not to be read to respondents is shown in ALL CAPS. Introductory text that may or may not be appropriate for all recruitment schemas is shaded. Variable names are shown in BOLD CAPS.

DOCUMENT HISTORY

DATE	VERSION	SUMMARY OF CHANGE/MILESTONE
5/24/2010	NA	HAUGEN AND SCHOENDORF determined questions to be included in the Low-Intensity CATI Pregnancy Screener
5/25/2010	20100524	HASHEMI incorporated questions into desired format
5/26/2010	20100526-bjh	HAUGEN made revisions and provided comments when necessary
5/27/2010	20100527	HASHEMI incorporated adjudication by J. Park and checked routing of questions extracted from other instruments
5/27/2010	20100527_jj	JAY added variable sources
5/27/2010	20100528	HASHEMI INCORPORATED EDITS FROM IRB TEAM
5/28/2010	20100528_jg	Jessica edits
6/2/2010	20100602	Comments from NCS PO
6/2/2010	20100602	INFORMAL SUBMISSION TO OMB
6/3/2010	20100603	INCORPORATE COMMENTS FROM OMB Change eligibility and routing to age of majority to age 49, no emancipated minors. [To be corrected – highlighted here]
6/7/2010	20100607	INCORPORATE EDITS FROM J. PARK
6/7/2010	20100607a	INCORPORATE EDITS FROM J. SLUTSMAN
		RECONCILE WITH DATA ELEMENTS TABLES
6/7/2010	20100607a	FORMAL SUBMISSION TO OMB
6/14/2010	20100614	Graber review and edits
6/17/2010	20100617_TCA	Tracked changes accepted
6/25/2010	20100625	Integrated comments from Slutsman, Schoendorf and Park
7/1/2010	20100701	Incorporated additional revisions
7/14/2010	20100714	Accept format changes
7/15/2010	20100714	SUBMISSION TO OMB
		INCORPORATE COMMENTS FROM OMB
		SUBMIT TO NICHD IRB
		RECONCILE WITH DATA ELEMENTS TABLES

NOTE: Italics denote anticipated development stages

cati

ASSUMPTIONS: potential LOW INTENSITY participants will be calling into study centers at will. scripts in this document represent this inbound calling scenario.

IC001/(TIME_STAMP_1) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

IF POSSIBLE, COLLECT TELEPHONE NUMBER FROM CALLER ID AND RECORD

(INCOMING) |___|___|___| - |___|___|___| - |___|___|___|___|

INITIAL CONVERSATION WITH INCOMING CALLER

Thank you for calling the National Children’s Study. I’d like to tell you a bit about the Study and see if you are able to take part. I will just need a few minutes of your time.

[NAME OF LOCAL ACADEMIC INSTITUTION] is part of this important research study aimed at improving the health and well-being of children.

VERBAL CONSENT TO SCREENING FOR STUDY ELIGIBILITY

IC013. I would like to ask you some questions to determine if you may be able to take part in the Study. Is this alright with you? You can skip over any question I ask or you can stop the interview at any time. The Information we collect from you is protected by law and we will keep all of it private.

general eligibility questions

EL001/(TIME_STAMP_2) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

HR001/ (R_GENDER)  IS RESPONDENT MALE OR FEMALE?

INTERVIEWER INSTRUCTION: SELECT BY OBSERVATION/LISTENING.

IF UNABLE TO DETERMINE, ASK “ Just to confirm, are you male or female?”

MALE……………………………………………………1 (MALE_R)

FEMALE ……………………………………………… 2 (TR003)/(R_FNAME) /(R_LNAME)

(MALE_R) We are speaking with women who are pregnant or may become pregnant in the future. Are there any women living in your household who are pregnant or who are [LOCAL AGE OF MAJORITY] years or older?

YES 1 (FEMALE_1)

NO 2 (MALE_END_1)

REFUSED -1 (MALE_END_1)

DON’T KNOW -2 (MALE_END_1)

(MALE_END_1) Right now we are speaking only with women. In the future we may be speaking to other members of households also. Thank you again for your call and please contact us again in the future if your household membership changes.

(FEMALE_1) Is she available to speak with me at this time?

YES 1 (TIME_STAMP_3)

NO 2 (NOT_AVAIL)

REFUSED -1 (NOT_AVAIL)

DON’T KNOW -2 (NOT_AVAIL)

INTERVIEWER INSTRUCTION: IF THERE IS MORE THAN ONE WOMAN IN HOUSEHOLD, AS TO SPEAK TO THE PREGNANT ONE FIRST. IF NOT AVAILABLE, ASK IF OTHERS ARE AVAILABLE.

(NOT_AVAIL) I would like to speak with her to see if she is eligible to take part in the Study.

(FIRST_NAME) Would you please tell me her first name?

____________________________________

FIRST NAME

REFUSED -1 (MALE_END_2) DON’T KNOW -2 (MALE_END_2)

INTERVIEWER INSTRUCTIONS: IF RESPONDENT REFUSES TO PROVIDE FIRST NAME, ASK FOR INITIALS

(R_PHONE_1) Would you please tell me a telephone number where she can be reached?

|___|___|___| - |___|___|___| - |___|___|___|___|

REFUSED -1 (MALE_END_2) DON’T KNOW -2 (MALE_END_2)

(MALE_END_2) Thank you again for your call. Please ask her to call us at [LOCAL SC TOLL-FREE NUMBER].

INTERVIEWER INSTRUCTION: END INTERVIEW

(TIME_STAMP_3) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

[WHEN SPEAKING TO A NEW FEMALE RESPONDENT]

Hello. I am [INTERVIEWER NAME] with the National Children’s Study. I would like to ask you some questions to determine if you may be eligible to participate in the Study? You can skip over any question I ask or you can stop the interview at any time. The information we collect from you is protected by law and we will keep all of it private.

TR003/(R_FNAME)/(R_LNAME) What is your full name?

_____________________ ___________________

FIRST NAME LAST NAME

REFUSED -1 EL003/ (PERSON_DOB) DON’T KNOW -2 EL003/ (PERSON_DOB)

INTERVIEWER INSTRUCTIONS:

• CONFIRM SPELLING.

• IF RESPONDENT REFUSES TO PROVIDE FIRST NAME, ASK FOR INITIALS

EL003/ (PERSON_DOB) What is your date of birth?

MONTH: |___|___|

M M

DAY: |___|___|

D D

YEAR: |___|___|___|___|

Y Y Y Y

REFUSED -1 (EL004) (AGE) DON’T KNOW -2 (EL004) (AGE)

PROGRAMMER INSTRUCTION:

• INCLUDE A SOFT EDIT/WARNING IF CALCULATED AGE IS LESS THAN LOCAL AGE OF MAJORITY OR GREATER THAN 50

• FORMAT PERSON_DOB AS YYYYMMDD

• CALCULATE AGE AND AGE_RANGE BASED ON RESPONSE; SKIP TO (AGE_ELIG)

• IF ONLY MONTH AND YEAR ARE PROVIDED, CALCULATE AGE AND AGE_RANGE AND SKIP TO (AGE_ELIG)

EL004/ (AGE) How old are you?

ENTER AGE AT LAST BIRTHDAY IN YEARS

|___|___| (AGE_ELIG)

AGE

REFUSED -1 (AGE_RANGE)

DON’T KNOW -2 (AGE_RANGE)

PROGRAMMER INSTRUCTION: INCLUDE A SOFT EDIT/WARNING IF AGE ENTERED IS LESS THAN 10 OR GREATER THAN 50; CALCULATE AGE_RANGE BASED ON RESPONSE

(AGE_RANGE) Which range best describes your age? Would you say…

Less than 18 1 (AGE_ELIG)

18-24 2 (AGE_ELIG)

25-34 3 (AGE_ELIG)

35-44 4 (AGE_ELIG)

45-49 5 (AGE_ELIG)

50-64 6 (AGE_ELIG)

65 or older 7 (AGE_ELIG)

REFUSED -1 (AGE_ELIG)

DON’T KNOW -2 (AGE_ELIG)

INTERVIEWER INSTRUCTION: DESCRIBE HOW THE ANSWER TO THIS QUESTION DETERMINES HER ELIGIBILITY AND THAT ALL DATA ARE KEPT CONFIDENTIAL AND SECURE.

(AGE_ELIG)

RESPONDENT IS AGE-ELIGIBLE 1 (TIME_STAMP_4)

RESPONDENT IS YOUNGER THAN AGE OF MAJORITY 2 (TIME_STAMP_4)

RESPONDENT IS OVER AGE 49 3 (TIME_STAMP_4)

AGE ELIGIBILITY IS UNKNOWN 4 (TIME_STAMP_4)

PROGRAMMER INSTRUCTION:  BASED ON REPORTED AGE OF RESPONDENT DETERMINE WHETHER SHE IS CONSIDERED A MINOR BASED ON LOCAL REQUIREMENTS (AGE_ELIG = 2).  IF RESPONDENT IS DETERMINED TO BE A MINOR, SET PPG_FIRST = 5

(TIME_STAMP_4) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

EL012/ (ADDRESS VARIABLES) What is your address?

ADDRESS 1 (ADDRESS_1)

• STREET NUMBER

• PRE-DIRECTIONAL

• STREET NAME

• STREET TYPE

• POST DIRECTIONAL

ADDRESS 2 (ADDRESS_2)

UNIT (UNIT)

• UNIT TYPE

• UNIT NUMBER

CITY (CITY)

STATE (STATE)

ZIP CODE (ZIP)

ZIP+4 (ZIP4) (EL014) (DU_ELIG_CONFIRM)

REFUSED -1 (DU_ELIG_CONFIRM)

DON’T KNOW -2 (DU_ELIG_CONFIRM)

INTERVIEWER INSTRUCTIONS: IF RESPONDENT REFUSES/DON’T KNOW: DESCRIBE HOW HER ELIGIBILITY IS DETERMINED BY HER RESIDENTIAL ADDRESS AND THAT ALL DATA ARE KEPT CONFIDENTIAL AND SECURE.

PROGRAMMER INSTRUCTIONS:

• IF SUFFICIENT ADDRESS INFORMATION IS PROVIDED GO TO (DU_ELIG_CONFIRM) AND SET VALUE AS APPROPRIATE

• IF RESPONDENT REFUSES TO PROVIDE ADDRESS INFORMATION GO TO

(DU_ELIG_CONFIRM) AND SET AS UNKNOWN

EL014/ (DU_ELIG_CONFIRM)

RESPONDENT LIVES IN AN ELIGIBLE DWELLING UNIT 1

(TIME_STAMP_5)

RESPONDENT DOES NOT LIVE IN AN ELIGIBLE DWELLING UNIT 2 (TIME_STAMP_5)

SET PPG_FIRST = 6

DWELLING UNIT ELIGIBILITY IS UNKNOWN 3 (TIME_STAMP_5)

INTERVIEWER INSTRUCTION: THIS QUESTION IS USED TO FLAG ELIGIBILITY.

FAMILIARITY WITH THE NATIONAL CHILDREN’S STUDY

FA001/(TIME_STAMP_5) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

FA002/ (KNOW_NCS) Before today, had you heard about the National Children’s Study?

YES 1 (FA003) (HOW_KNOW_NCS)

NO 2 (ELIG)

REFUSED -1 (ELIG) DON’T KNOW -2 (ELIG)

FA003/(HOW_KNOW_NCS) How did you hear about the National Children’s Study?

INTERVIEWER INSTRUCTION: SELECT ALL THAT APPLY AND PROBE FOR ANY OTHER MEANS

ADVANCE LETTER MAILED BY NCS 1

HOUSEHOLD ENUMERATION 2

CONTINUOUS TRACKING OF DU – NEW MEMBER OF EXISTING HOUSEHOLD 3

CONTINUOUS TRACKING OF DU – NEW HOUSEHOLD 4

PRENATAL CARE PROVIDER 5

OTHER HEALTH CARE PROVIDER 6

OTHER NCS RESPONDENT 7

FRIEND 8

NEIGHBOR 9

FAMILY MEMBER 10

CO-WORKER 11

SELF/RESPONDENT REFERRAL 12

SCHOOL 13

WIC OR OTHER SOCIAL AGENCY 14

RELIGIOUS ORGANIZATION 15

COMMUNITY PARTNERS/OUTREACH EVENT 16

MEDIA: PRINT MEDIA 17

MEDIA: TV 18

MEDIA: RADIO 19

SOCIAL NETWORKING MEDIA (E.G., INTERNET, FACEBOOK, MYSPACE, BLOGS, ETC.) 20

OTHER -5 (HOW_KNOW_NCS_OTH)

REFUSED -1

DON’T KNOW -2

FA008/ (HOW_KNOW_NCS_OTH)

SPECIFY ___________________________

REFUSED -1

DON’T KNOW -2

(ELIG) PROGRAMMER INSTRUCTIONS: PROGRAM SKIP PATTERNS ACCORDING TO TABLE BELOW

		DU_ELIG_CONFIRM
			1	2	3
AGE_ELIG			ELIGIBLE DWELLING UNIT	INELIGIBLE DWELLING UNIT	UNKNOWN ELIGIBILITY
	1	AGE-ELIGIBLE	TIME_STAMP_6	TIME_STAMP_6	TIME_STAMP_6
	2	YOUNGER THAN AGE OF MAJORITY	TIME_STAMP_11	TIME_STAMP_11	TIME_STAMP_11
	3	OVER AGE 49	TIME_STAMP_6	TIME_STAMP_6	TIME_STAMP_6
	4	UNKNOWN	TIME_STAMP_12	TIME_STAMP_12	TIME_STAMP_12

PREGNANCY SCREENER

PS001/(TIME_STAMP_6) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

PS002.We are asking women of childbearing age a few questions about pregnancy. Not all women who answer these questions will be able to take part in the National Children’s Study now, but almost every woman who answers these questions will have a chance to take part in some way in the future. We first want to know….

PS004./(PREGNANT) IF ADULT IS KNOWN TO BE PREGNANT, ADD [Just to confirm,] Are you pregnant now?

YES 1 (PS006) (ORIG_DUE_DATE)

SET (PPG_FIRST) = 1

NO, NO ADDITIONAL INFORMATION PROVIDED 2 (PS005)

(IF VOLUNTEERED BY RESPONDENT)

NO, RECENTLY LOST PREGNANCY (MISCARRIAGE/ABORTION) 3 (DE001)(TIME_STAMP_8)

SET (PPG_FIRST) = 3

NO, RECENTLY GAVE BIRTH 4

(DE001) (TIME_STAMP_8)

SET (PPG_FIRST) = 4

NO, UNABLE TO HAVE CHILDREN (HYSTERECTOMY, TUBAL LIGATION) 5

(PS014) (HYSTER)

REFUSED -1 (TIME_STAMP_7)

DON’T KNOW -2 (TIME_STAMP_7)

PS005. IF PREGNANT = NO - NO ADD’L INFO AND AGE_ELIG = 1 GO TO (TIME_STAMP_7)

IF PREGNANT = NO - NO ADD’L INFO AND AGE _ELIG = 3 OR 4…GO TO (TIME_STAMP_8); SET (PPG_FIRST) = 5

PS006/(ORIG_DUE_DATE)] [Congratulations.] When is your baby due?

MONTH: |___|___|

M M

DAY: |___|___|

D D

YEAR: |___|___|___|___|

Y Y Y Y

REFUSED -1 (PS008) /(DATE_PERIOD)

DON’T KNOW -2 (PS008) /(DATE_PERIOD)

INTERVIEWER INSTRUCTION:

• ENTER A TWO DIGIT MONTH, TWO DIGIT DAY, AND A FOUR DIGIT YEAR

• IF RESPONSE WAS DETERMINED TO BE INVALID, ASK QUESTION AGAIN AND PROBE FOR VALID RESPONSE

PROGRAMMER INSTRUCTIONS:

• CHECK REPORTED DUE DATE AGAINST CURRENT DATE; DISPLAY APPROPRIATE MESSAGE:

  • IF DATE IS MORE THAN 9 MONTHS AFTER CURRENT DATE, DISPLAY INTERVIEWER INSTRUCTION: “YOU HAVE ENTERED A DATE THAT IS MORE THAN 9 MONTHS FROM TODAY. RE-ENTER DATE.”

  • IF DATE IS MORE THAN 1 MONTH BEFORE CURRENT DATE, DISPLAY INTERVIEWER INSTRUCTION: “YOU HAVE ENTERED A DATE THAT OCCURRED MORE THAN A MONTH BEFORE TODAY. RE-ENTER DATE.”

  • IF VALID DUE DATE WAS PROVIDED, SET (ORIG_DUE_DATE) = YYYYMMDD AS REPORTED ; GO TO PS008 (DATE_PERIOD); SET (PPG_FIRST) = 1

  • IF NO VALID DATE IS GIVEN  GO TO PS008 (DATE_PERIOD)

PS008/(DATE_PERIOD) What was the first day of your last menstrual period?

MONTH: |___|___|

M M

DAY: |___|___|

D D

YEAR: |___|___|___|___|

Y Y Y Y

IF VALID RESPONSE PROVIDED (DE001)/(TIME_STAMP_8)

REFUSED -1 (PS009) (WEEKS_PREG)

DON’T KNOW -2 (PS009) (WEEKS_PREG)

INTERVIEWER INSTRUCTION:

• ENTER A TWO DIGIT MONTH, TWO DIGIT DAY, AND A FOUR DIGIT YEAR

• IF RESPONSE WAS DETERMINED TO BE INVALID, ASK QUESTION AGAIN AND PROBE FOR VALID RESPONSE

PROGRAMMER INSTRUCTIONS:

• IF RESPONDENT PROVIDED VALID DATE IN (ORIG_DUE_DATE) SKIP TO (TIME_STAMP_8)

• CHECK REPORTED MENSTRUAL DATE AGAINST CURRENT DATE; DISPLAY APPROPRIATE MESSAGE:

  • IF DATE IS MORE THAN 10 MONTHS BEFORE CURRENT DATE, DISPLAY INTERVIEWER INSTRUCTION: “YOU HAVE ENTERED A DATE THAT IS MORE THAN 10 MONTHS BEFORE TODAY. CONFIRM DATE. IF DATE IS CORRECT, ENTER ‘DON’T KNOW’.”

  • IF DATE IS AFTER CURRENT DATE, DISPLAY INTERVIEWER INSTRUCTION: “YOU HAVE ENTERED A DATE THAT HAS NOT OCCURRED YET. RE-ENTER DATE.”

  • IF VALID DATE WAS PROVIDED, CALCULATE DUE DATE FROM THE FIRST DATE OF LAST MENSTRUAL PERIOD AND SET (ORIG_DUE_DATE) (YYYYMMDD) = (DATE_PERIOD) + 280 DAYS; GO TO (DE001)/(TIME_STAMP_8); SET (PPG_FIRST) = 1

  • IF NO VALID DATE IS GIVEN  GO TO PS009 (WEEKS_PREG)

PS009/(WEEKS_PREG) How many weeks pregnant are you now? If you’re not sure, please make your best guess.

|___|___|

NUMBER OF WEEKS

IF VALID RESPONSE PROVIDED (DE001)/(TIME_STAMP_8)

REFUSED -1 PS010 (MONTH_PREG)

DON’T KNOW -2 PS010 (MONTH_PREG)

INTERVIEWER INSTRUCTION:

• IF RESPONSE WAS DETERMINED TO BE INVALID, ASK QUESTION AGAIN AND PROBE FOR VALID RESPONSE

PROGRAMMER INSTRUCTIONS:

• REJECT RESPONSES THAT ARE EITHER < 1 WEEK OR GREATER THAN 43 WEEKS

• IF VALID RESPONSE WAS PROVIDED, CALCULATE PS006 (ORIG_DUE_DATE) (YYYYMMDD)=TODAY’S DATE + (280 DAYS – WEEKS_PREG *7); GO TO (DE001)/(TIME_STAMP_8); SET (PPG_FIRST) = 1

• IF NO VALID DATE IS CALCULABLE  GO TO PS010 (MONTH_PREG)

PS010/(MONTH_PREG) How many months pregnant are you now? If you’re not sure, please make your best guess.

|___|___|

NUMBER OF MONTHS

IF VALID RESPONSE PROVIDED (DE001)/(TIME_STAMP_8)

REFUSED -1 (PS011) (TRIMESTER)

DON’T KNOW -2 (PS011) (TRIMESTER)

INTERVIEWER INSTRUCTION:

• IF RESPONSE WAS DETERMINED TO BE INVALID, ASK QUESTION AGAIN AND PROBE FOR VALID RESPONSE

PROGRAMMER INSTRUCTIONS:

• REJECT RESPONSES THAT ARE EITHER < 1 MONTH OR GREATER THAN 12 MONTHS

• IF VALID RESPONSE WAS PROVIDED, CALCULATE DUE DATE AS FROM NUMBER OF MONTHS PREGNANT WHERE (ORIG_DUE_DATE) (YYYYMMDD)=TODAY’S DATE + (280 DAYS –((MONTH_PREG*30) -15)); GO TO (DE001)/(TIME_STAMP_8); SET (PPG_FIRST) = 1

• IF NO VALID RESPONSE IS CALCULABLE  GO TO PS011 (TRIMESTER)

PS011/(TRIMESTER) Are you currently in your First, Second, or Third trimester?

1^ST TRIMESTER (1-3 MONTHS PREGNANT) 1 (TIME_STAMP_8)

2^ND TRIMESTER (4-6 MONTHS PREGNANT) 2 (TIME_STAMP_8)

3^RD TRIMESTER (7-9 MONTHS PREGNANT) 3 (TIME_STAMP_8)

REFUSED -1 (TIME_STAMP_8)

DON’T KNOW -2 (TIME_STAMP_8)

PROGRAMMER INSTRUCTIONS: CALCULATE DUE DATE AS FROM REPORTED TRIMESTER

• 1ST TRIMESTER: ORIG_DUE_DATE = TODAY’S DATE + (280 DAYS – 46 DAYS)

• 2ND TRIMESTER: (ORIG_DUE_DATE) = TODAY’S DATE + (280 DAYS – 140 DAYS)

• 3RD TRIMESTER: (ORIG_DUE_DATE) = TODAY’S DATE + (280 DAYS – 235 DAYS)

• DON’T KNOW/REFUSED: (ORIG_DUE_DATE) = TODAY’S DATE + (280 DAYS – 140 DAYS)

• SET (ORIG_DUE_DATE) = YYYYMMDD AS CALCULATED

• SET (PPG_FIRST) = 1

(TIME_STAMP_7) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

PS013/(TRYING) Are you currently trying to become pregnant?

YES 1 (DE001)/(TIME_STAMP_8); SET (PPG_FIRST) =2

NO, NO ADDITIONAL INFORMATION PROVIDED 2 (PS014)/(HYSTER)

NO, RECENTLY LOST PREGNANCY (MISCARRIAGE OR ABORTION) 3

(DE001)/(TIME_STAMP_8); SET (PPG_FIRST) = 3

NO, UNABLE TO HAVE CHILDREN (HYSTERECTOMY, TUBAL LIGATION) 4

(PS014)/ (HYSTER)

REFUSED -1 (PS014)/ (HYSTER)

DON’T KNOW -2 (PS014)/ (HYSTER)

PS014/(HYSTER) Do any of the following apply to you? Have you had your uterus removed, sometimes called a hysterectomy?

YES 1 (TIME_STAMP_8); SET (PPG_FIRST) = 5

NO 2 (PS015)/ (OVARIES)

REFUSED -1 (PS015)/ (OVARIES)

DON’T KNOW -2 (PS015)/ (OVARIES)

PS015/(OVARIES) (READ IF NECESSARY: Have you had…) both ovaries removed?

YES 1 (TIME_STAMP_8); SET (PPG_FIRST) = 5

NO 2 (PS016)/(TUBES_TIED)

REFUSED -1 (PS016)/(TUBES_TIED)

DON’T KNOW -2 (PS016)/(TUBES_TIED)

PS016/(TUBES_TIED) (READ IF NECESSARY: Have you had…) your tubes tied?

YES 1(TIME_STAMP_8); SET (PPG_FIRST) = 5

NO 2 (PS017)/ (MENOPAUSE)

REFUSED -1 (PS017)/ (MENOPAUSE)

DON’T KNOW -2 (PS017)/ (MENOPAUSE)

PS017/(MENOPAUSE) (READ IF NECESSARY: Have you…) stopped having your period or gone through menopause?

YES 1(TIME_STAMP_8); SET (PPG_FIRST) = 5

NO 2 (PS018)/ (MED_UNABLE)

REFUSED -1 (PS018)/ (MED_UNABLE)

DON’T KNOW -2 (PS018)/ (MED_UNABLE)

PS018/(MED_UNABLE) Is there any other medical reason why you believe you cannot become pregnant?

YES 1 (PS019)/(MED_UNABLE_OTH)

NO 2 (DE001)/(TIME_STAMP_8); SET (PPG_FIRST) = 4

REFUSED -1 (DE001)/(TIME_STAMP_8); SET (PPG_FIRST) = 4

DON’T KNOW -2 (DE001)/(TIME_STAMP_8); SET (PPG_FIRST) = 4

PS019. (MED_UNABLE_OTH)

SPECIFY _____________________________

(DE001)/(TIME_STAMP_8); SET (PPG_FIRST) = 4

REFUSED -1 (DE001)/(TIME_STAMP_8); SET (PPG_FIRST) = 4

DON’T KNOW -2 (DE001)/(TIME_STAMP_8); SET (PPG_FIRST) = 4

DEMOGRAPHIC QUESTIONS

DE001/ (TIME_STAMP_8) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

IF PPG_FIRST = 3 (RECENT PREGNANCY LOSS)

I’m so sorry about your loss. I have some additional questions to ask if that is okay.

DE002/(MARISTAT) I’d like to ask about your marital status. Are you:

Married, 1 (DE003) /(EDUC)

Not married but living together with a partner 2 (DE003) /(EDUC)

Never been married? 3 (DE003) /(EDUC) Divorced, 4 (DE003) /(EDUC)

Separated 5 (DE003) /(EDUC)

Widowed, 6 (DE003) /(EDUC)

REFUSED -1 (DE003) /(EDUC) DON’T KNOW -2 (DE003) /(EDUC)

DE003/(EDUC) What is the highest degree or level of school you have completed?

LESS THAN A HIGH SCHOOL DIPLOMA OR GED 1 (DE004) /(EMPLOY) HIGH SCHOOL DIPLOMA OR GED 2 (DE004) /(EMPLOY) SOME COLLEGE BUT NO DEGREE 3 (DE004) /(EMPLOY)

ASSOCIATE DEGREE 4 (DE004) /(EMPLOY) BACHELOR’S DEGREE (e.g., BA, BS) 5 (DE004) /(EMPLOY) POST GRADUATE DEGREE (e.g., Masters or Doctoral) 6 (DE004) /(EMPLOY)

REFUSED -1 (DE004) /(EMPLOY) DON’T KNOW -2 (DE004) /(EMPLOY)

DE004/(EMPLOY) Last week were you working full time, part time, going to school, keeping house, or something else?

WORKING FULL TIME 1 (DE005) /(ETHNICITY)

WORKING PART TIME 2 (DE005) /(ETHNICITY)

WITH A JOB, BUT NOT AT WORK BECAUSE OF TEMPORARY ILLNESS, VACATION, STRIKE 3 (DE005) /(ETHNICITY)

UNEMPLOYED/LAID OFF/LOOKING FOR WORK 4 (DE005) /(ETHNICITY)

RETIRED 5 (DE005) /(ETHNICITY)

IN SCHOOL 6 (DE005) /(ETHNICITY)

KEEPING HOUSE 7 (DE005) /(ETHNICITY)

OTHER -5 (EMPLOY_OTH)

REFUSED -1 (DE005) /ETHNICITY)

DON’T KNOW -2 (DE005) /(ETHNICITY)

INTERVIEWER INSTRUCTION: PROBE AS NEEDED

DE004A. (EMPLOY_OTH)

SPECIFY _____________________________ (DE005)/(ETHNICITY)

REFUSED -1 (DE005)/(ETHNICITY)

DON’T KNOW -2 (DE005)/(ETHNICITY)

DE005/(ETHNICITY) Do you consider yourself to be Hispanic, or Latina?

YES 1 (DE006) /(RACE)

NO 2 (DE006) /(RACE)

REFUSED -1 (DE006) /(RACE)

DON’T KNOW -2 (DE006) /(RACE)

DE006/(RACE) What race do you consider yourself to be? You may select one or more.

PROBE: Anything else?

SELECT ALL THAT APPLY.

White, 1 (DE007)/(PERSON_LANG)

Black or African American, 2 (DE007) /(PERSON_LANG)

American Indian or Alaska Native, 3 (DE007) /(PERSON_LANG)

Asian, or 4 (DE007) /(PERSON_LANG)

Native Hawaiian or Other Pacific Islander? 5 (DE007) /(PERSON_LANG)

SOME OTHER RACE? -5 (DE006A)/ (RACE_OTH)

REFUSED -1 (DE007) /(PERSON_LANG)

DON’T KNOW -2 (DE007) /(PERSON_LANG)

INTERVIEWER INSTRUCTION. CODE “OTHER” ONLY USE IF VOLUNTEERED.

DE006A. (RACE_OTH)

SPECIFY _____________________________ (DE007) /(PERSON_LANG)

REFUSED -1 (DE007) /(PERSON_LANG)

DON’T KNOW -2 (DE007) /(PERSON_LANG)

DE007/(PERSON_LANG) What is the primary language spoken in your home?

ENGLISH 1 (TIME_STAMP_9)

SPANISH 2 (TIME_STAMP_9)

ARABIC 3 (TIME_STAMP_9)

CHINESE 4 (TIME_STAMP_9)

FRENCH 5 (TIME_STAMP_9)

FRENCH CREOLE 6 (TIME_STAMP_9)

GERMAN 7 (TIME_STAMP_9)

ITALIAN 8 (TIME_STAMP_9)

KOREAN 9 (TIME_STAMP_9)

POLISH 10 (TIME_STAMP_9)

RUSSIAN 11 (TIME_STAMP_9)

TAGALOG 12 (TIME_STAMP_9)

VIETNAMESE 13 (TIME_STAMP_9)

URDU 14 (TIME_STAMP_9)

PUNJABI 15 (TIME_STAMP_9)

BENGALI 16 (TIME_STAMP_9)

FARSI 17 (TIME_STAMP_9)

OTHER -5 (PERSON_LANG_OTH)

REFUSED -1 (TIME_STAMP_9)

DON’T KNOW -2 (TIME_STAMP_9)

DE008/(PERSON_LANG_OTH)

SPECIFY _____________________________ (TIME_STAMP_9)

REFUSED -1 (TIME_STAMP_9)

DON’T KNOW -2 (TIME_STAMP_9)

(TIME_STAMP_9) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

DE009. Now I’m going to ask a few questions about your income. Family income is important in analyzing the data we collect and is often used in scientific studies to compare groups of people who are similar. Please remember that all the information you provide is confidential.

Please think about your total combined family income during 2009 for all members of the family.

DE010/(HH_MEMBERS) How many household members are supported by your total combined family income?

|___|___|

NUMBER

REFUSED -1 (DE011) /(INCOME)

DON’T KNOW -2 (DE011) /(INCOME)

PROGRAMMER INSTRUCTION: RESPONSE MUST BE > 0; INCLUDE A SOFT EDIT IF RESPONSE IS > 15

DE010A/(NUM_CHILD) How many of those people are children? Please include anyone under 18 years or anyone older than 18 years and in high school

|___|___| (INCOME)

NUMBER

REFUSED -1 (DE011) /(INCOME)

DON’T KNOW -2 (DE011) /(INCOME)

PROGRAMMER INSTRUCTIONS:

• INCLUDE HARD EDIT IF RESPONSE > HH_MEMBERS

• INCLUDE SOFT EDIT IF RESPONSE > 10

DE011/(INCOME_4CAT) Of these income groups, which category best represents your total combined family income during the last calendar year?

Less than $30,000 1 (TR001)/(TIME_STAMP_10)

$30,000 - $49,000 2 (TR001)/(TIME_STAMP_10) $50,000 - $99,999 3 (TR001)/(TIME_STAMP_10) $100,000 or more 4 (TR001)/(TIME_STAMP_10)

REFUSED -1 (TR001)/(TIME_STAMP_10) DON’T KNOW -2 (TR001)/(TIME_STAMP_10)

TRACING QUESTIONS

TR001/(TIME_STAMP_10) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

TR002.These next few questions will help us to contact you again in the future.

TR005/(PHONE_NBR) What is the best phone number to reach you?

ENTER PHONE NUMBER AND CONFIRM.

|___|___|___| - |___|___|___| - |___|___|___|___| (PHONE_TYPE)

RESPONDENT HAS NO TELEPHONE 1 (TR006)/(PHONE_NBR_OTH)

REFUSED -1 TR007/(HOME_PHONE)

DON’T KNOW -2 TR007/(HOME_PHONE)

TR006. (PHONE_NBR_OTH): IF RESPONDENT DOES NOT HAVE A TELEPHONE NUMBER, ASK WHERE RESPONDENT RECEIVES TELEPHONE CALLS, EVEN IF SHE DOES NOT HAVE HER OWN PHONE. ASK FOR AND RECORD THAT NUMBER

ENTER PHONE NUMBER AND CONFIRM.

|___|___|___| - |___|___|___| - |___|___|___|___| (PHONE_TYPE)

REFUSED -1 (TR009) (HOME_PHONE)

DON’T KNOW -2 (TR009) (HOME_PHONE)

TR007/(PHONE_TYPE) Is that your home, work, cell, or another phone number?

CONFIRM IF KNOWN.

HOME 1 (TR105) (CELL_PHONE_1)

WORK 2 (TR009)/(HOME_PHONE)

CELL 3 (TR009)/(HOME_PHONE)

FRIEND/RELATIVE 4 (TR009)/(HOME_PHONE)

OTHER -5 (TR008) (PHONE_TYPE_OTH)

REFUSED -1 (TR009)/(HOME_PHONE)

DON’T KNOW -2 (TR009)/(HOME_PHONE)

PROGRAMMER INSTRUCTION: IF TR007 (PHONE_TYPE) = HOME, THEN GO TO (CELL_PHONE_1).

TR008. (PHONE_TYPE_OTH)

SPECIFY _____________________________ (TR009) (HOME_PHONE)

REFUSED -1 (TR009) (HOME_PHONE)

DON’T KNOW -2 (TR009) (HOME_PHONE)

TR009/(HOME_PHONE) What is your home phone number?

ENTER PHONE NUMBER AND CONFIRM.

|___|___|___| - |___|___|___| - |___|___|___|___| (CELL_PHONE_1)

NO HOME NUMBER 1 (TR105) (CELL_PHONE_1)

REFUSED -1 (TR105) (CELL_PHONE_1)

DON’T KNOW -2 (TR105) (CELL_PHONE_1)

TR105/(CELL_PHONE_1). Do you have a personal cell phone?

PROGRAMMER INSTRUCTION: IF TR007 (PHONE_TYPE) = CELL, THEN GO TO (CELL_PHONE_2) AND DO NOT ASK CELL_PHONE_1

YES 1 (CELL_PHONE_2)

NO 2 (TR010)/(SAME_ADDR)

REFUSED -1 (TR010)/(SAME_ADDR)

DON’T KNOW -2 (TR010)/(SAME_ADDR)

TR106./(CELL_PHONE_2). May we use your personal cell phone to make future study appointments or for appointment reminders?

YES 1 (CELL_PHONE_3)

NO 2 (CELL_PHONE_3)

REFUSED -1 (CELL_PHONE_3)

DON’T KNOW -2 (CELL_PHONE_3)

TR107/(CELL_PHONE_3). Do you send and receive text messages on your personal cell phone?

YES 1 (CELL_PHONE_4)

NO 2 (TR109)/(CELL_PHONE)

REFUSED -1 (TR109)/(CELL_PHONE)

DON’T KNOW -2 (TR109)/(CELL_PHONE)

TR108/(CELL_PHONE_4). May we send text messages to make future study appointments

or for appointment reminders?

YES 1 (TR109)/(CELL_PHONE)

NO 2 (TR109)/(CELL_PHONE)

REFUSED -1 (TR109)/(CELL_PHONE)

DON’T KNOW -2 (TR109)/(CELL_PHONE)

TR109/(CELL_PHONE).What is your personal cell phone number?

PROGRAMMER INSTRUCTION: IF TR007 (PHONE_TYPE) = CELL AND VALID NUMBER PROVIDED IN (PHONE_NBR) OR (PHONE_NBR_OTH) THEN SKIP CELL_PHONE AND GO TO SAME_ADDR

|___|___|___| - |___|___|___| - |___|___|___|___| (TR010)/(SAME_ADDR)

PHONE NUMBER

REFUSED -1 (TR010)/(SAME_ADDR)

DON’T KNOW -2 (TR010)/(SAME_ADDR)

TR010/(SAME_ADDR) Is your mailing address the same as your street address?

YES 1 (TR012)/(HAVE_EMAIL)

NO 2 (TR011)/(MAILING ADDRESS VARIABLES)

REFUSED -1 (TR011)/(MAILING ADDRESS VARIABLES)

DON’T KNOW -2 (TR011)/(MAILING ADDRESS VARIABLES)

TR011/(MAILING ADDRESS VARIABLES) What is your mailing address?

INTERVIEWER INSTRUCTION: PROMPT AS NECESSARY TO COMPLETE INFORMATION

_____________________________________________________

(MAIL_ADDRESS1) ADDRESS 1 - STREET/PO BOX

_____________________________________________________

(MAIL_ADDRESS2) ADDRESS 2

_____________________________________________________

(MAIL_UNIT) UNIT

____________________________________________________

(MAIL_CITY) CITY

|___|___| |___|___|___|___|___| |___|___|___|___

STATE ZIP CODE ZIP+4

(MAIL_STATE) (MAIL_ZIP) (MAIL_ZIP4)

REFUSED -1 (TR012)/ (HAVE_EMAIL)

DON’T KNOW -2 (TR012)/ (HAVE_EMAIL)

TR012/(HAVE_EMAIL) Do you have an email address?

YES 1 (TR013)/ (EMAIL)

NO 2 (TR016)/ (PLAN_MOVE)

REFUSED -1 (TR016)/ (PLAN_MOVE)

DON’T KNOW -2 (TR016)/ (PLAN_MOVE)

TR013/(EMAIL) What is the best email address to reach you?

PROGRAMMER INSTRUCTION: SHOW EXAMPLE OF VALID EMAIL ADDRES SUCH AS [email protected]

ENTER E-MAIL ADDRESS: ___________________________________

REFUSED -1 (TR016)/ (PLAN_MOVE)

DON’T KNOW -2 (TR016)/ (PLAN_MOVE)

TR014/(EMAIL_TYPE) Is that your personal e-mail, work e-mail, or a family or shared e-mail

address?

PERSONAL 1 (TR016)/ (PLAN_MOVE)

WORK 2 (TR016)/ (PLAN_MOVE)

FAMILY/SHARED 3 (TR015)/ (EMAIL_SHARE)

REFUSED -1 (TR016)/ (PLAN_MOVE)

DON’T KNOW -2 (TR016)/ (PLAN_MOVE)

TR015/(EMAIL_SHARE)

PROGRAMMER INSTRUCTIONS: IF RESPONDENT REPORTED A SHARED EMAIL ADDRESS IN (EMAIL_TYPE), SET (EMAIL_SHARE) AS APPROPRIATE THEN GO TO (TR016) (PLAN_MOVE)

YES 1 (TR016) (PLAN_MOVE)

NO 2 (TR016) (PLAN_MOVE)

TR016/(PLAN_MOVE) Do you plan on moving from your present address in the next few months?

YES 1 (TR017) (WHERE_MOVE)

NO 2 (CS001)/(TIME_STAMP_11)

REFUSED -1 (CS001)/ (TIME_STAMP_11)

DON’T KNOW -2 (CS001)/ (TIME_STAMP_11)

TR017/(WHERE_MOVE) Do you know where you will be moving?

YES 1 (TR018)/ (MOVE_INFO)

NO 2 (TR020)/ (WHEN_MOVE)

REFUSED -1 (TR020)/ (WHEN_MOVE)

DON’T KNOW -2 (TR020)/ (WHEN_MOVE)

TR018/(MOVE_INFO) What is the address of your new home?

ADDRESS KNOWN 1 (NEW ADDRESS VARIABLES)

OUT OF THE COUNTRY 2 (TR020)/(WHEN_MOVE)

PO BOX ADDRESS ONLY 3 (NEW ADDRESS VARIABLES)

REFUSED -1 (TR020)/(WHEN_MOVE)

DON’T KNOW -2 (TR020)/ (WHEN_MOVE)

TR019/(NEW ADDRESS VARIABLES) ENTER ADDRESS

INTERVIEWER INSTRUCTION: PROBE AND ENTER AS MUCH INFORMATION AS R KNOWS.

_____________________________________________________

(NEW_ADDRESS1) ADDRESS 1 - STREET/PO BOX

_____________________________________________________

(NEW_ADDRESS2) ADDRESS 2

_____________________________________________________

(NEW_UNIT) UNIT

____________________________________________________

(NEW_CITY) CITY

|___|___| |___|___|___|___|___| |___|___|___|___

STATE ZIP CODE ZIP+4

(NEW_STATE) (NEW_ZIP) (NEW_ZIP4)

REFUSED……………………………………………………………………………..-1

DON’T KNOW…………………………………………………………………………-2

TR020/ (WHEN_MOVE) Do you know when you will be moving?

YES 1 (TR021)/ (DATE_MOVE)

NO 2 (CS001) / (TIME_STAMP_11)

REFUSED -1 (CS001) / (TIME_STAMP_11)

DON’T KNOW -2 (CS001) / (TIME_STAMP_11)

TR021/(DATE_MOVE) When will you move?

MONTH: |___|___|

M M

YEAR: |___|___|___|___|

Y Y Y Y

PROGRAMMER INSTRUCTION: FORMAT DATE_MOVE AS YYYYMM

REFUSED -1 (CS001) / (TIME_STAMP_11)

DON’T KNOW -2 (CS001) / (TIME_STAMP_11)

CLOSING STATEMENTS

CS001/(TIME_STAMP_11) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

CS002/(PPG_FIRST)

PROGRAMMER INSTRUCTIONS: DISPLAY APPROPRIATE PPG_FIRST ASSIGNMENT FOR RESPONDENT

PREGNANT AND ELIGIBLE 1 (CS003)

HIGH PROBABILITY –TRYING TO CONCEIVE 2 (CS004)

HIGH PROBABILITY – RECENT PREGNANCY LOSS 3 (CS005)

OTHER PROBABILITY – NOT PREGNANT AND NOT TRYING 4 (CS006)

UNABLE TO CONCEIVE, OR AGE-INELIGIBLE 5 (CS007)

INELIGIBLE DWELLING UNIT 6 (CS008)

CS003. Thank you for taking the time to answer these questions. You are able to be part of this important study because of your due date. I would like to tell you more about it and give you all the information you need to decide if you would like to be part of the study.

CS004. Thank you for taking the time to answer these questions. You are able to be part of this important study because you are currently trying to become pregnant. I would like to tell you more about it and give you some information to help you decide if you would like to be part of the study.

CS005. [I’m so sorry to hear that you’ve lost your baby. I know this can be a hard time.] Because your address is in the study area you are able to be part of this important study. I would like to tell you more about it and give you some information to help you decide if you would like to be part of the study.

CS006. Thank you for taking the time to answer these questions. Because your address is in the study area you are able to be part of this important study. I would like to tell you more about it and give you some information to help you decide if you would like to be part of the study.

CS007. Thank you for taking the time to answer these questions. Based on what you’ve told me, we will not ask you to take part in the study. Because your address is in the study area, we may be back in touch at later time to update your household information.

CS008. Thank you for taking the time to answer these questions. Based on what you’ve told me, we will not ask you to take part in the study.

CONCLUSION

C0001/(TIME_STAMP_12) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

(OTHER_FEMALE). Finally, are there any other women in your household who are age [LOCAL AGE OF MAJORITY]-49 or pregnant?

YES 1 (FEMALE_1)

NO 2 (FEMALE_END_1)

REFUSED -1 (FEMALE_END_1)

DON’T KNOW -2 (FEMALE_END_1)

PROGRAMMER INSTRUCTION: IF (OTHER_FEMALE) = YES; LOOP BACK TO (FEMALE_1) AND ATTEMPT TO COMPLETE ANOTHER PREGNANCY SCREENER WITH OTHER HOUSEHOLD MEMBER. REPEAT FOR EACH IDENTIFIED FEMALE

(FEMALE_END_1) Thank you again for your time.

FINAL INTERVIEWER-COMPLETED QUESTIONS

(TIME_STAMP_13) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

FI002/(ENGLISH) WAS THIS DATA COLLECTION SESSION CONDUCTED IN ENGLISH?

YES 1 (FI005)/(INTERPRET)

NO 2 (FI003)/(CONTACT_LANG)

FI003/(CONTACT_LANG) WHAT OTHER LANGUAGE WAS USED TO CONDUCT THIS SESSION?

SPANISH 1 (FI005)

ARABIC 2 (FI005)

CHINESE 3 (FI005)

FRENCH 4 (FI005)

FRENCH CREOLE 5 (FI005)

GERMAN 6 (FI005)

ITALIAN 7 (FI005)

KOREAN 8 (FI005)

POLISH 9 (FI005)

RUSSIAN 10 (FI005)

TAGALOG 11 (FI005)

VIETNAMESE 12 (FI005)

URDU 13 (FI005)

PUNJABI 14 (FI005)

BENGALI 15 (FI005)

FARSI 16 (FI005)

OTHER -5 (FI004)/(CONTACT_LANG_OTH)

FI004/(CONTACT_LANG_OTH)

SPECIFY _____________________________ (FI005)

FI005/(INTERPRET) WAS AN INTERPRETER USED?

YES 1 (FI006)/(CONTACT_INTERPRET)

NO 2 (FI008)/(TIME_STAMP_14)

FI006/(CONTACT_INTERPRET) WHAT TYPE OF INTERPRETER WAS USED?

BILINGUAL INTERVIEWER 1

IN-PERSON PROFESSIONAL INTERPRETER 2

IN-PERSON FAMILY MEMBER INTERPRETER 3

LANGUAGE-LINE INTERPRETER 4

VIDEO INTERPRETER 5

SIGN LANGUAGE INTERPRETER 6

OTHER (CONTACT_INTERPRET_OTH) -5 (FI007)

FI007. (CONTACT_INTERPRET_OTH)

SPECIFY _____________________________ (FI008) /(TIME_STAMP_14)

(TIME_STAMP_14) PROGRAMMER INSTRUCTION: INSERT DATE/TIME STAMP

PROGRAMMER INSTRUCTION:

• IF DU_ELIG_CONFIRM = 3 (UNKNOWN) AND NEW INFORMATION IS RECORDED IN MAILING ADDRESS VARIABLES OR NEW ADDRESS VARIABLES UPDATE DU_ELIG_CONFIRM TO REFLECT THIS INFORMATION

PROGRAMMER INSTRUCTION: ATTEMPT TO ENROLL WOMEN WHO ARE PREGNANT OR TRYING TO BECOME PREGNANT, AND MEET AGE AND RESIDENCE ELIGIBILITY REQUIREMENTS

IF PPG_FIRST = 1 AND AGE_ELIG = 1 OR 3 AND DU_ELIG_CONFIRM = 1

OR

IF PPG_FIRST = 2 AND AGE_ELIG = 1 AND DU_ELIG_CONFIRM = 1

 GO TO LOW-INTENSITY INFORMED CONSENT PROCESS

Public reporting burden for this collection of information is estimated to average 15 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0593*). Do not return the completed form to this address.