[Federal Register Volume 80, Number 97 (Wednesday, May 20, 2015)]
[Notices]
[Pages 29010-29012]
[FR Doc No: 2015-12170]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0247]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Formal Meetings With Sponsors
and Applicants for Prescription Drug User Fee Act Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
contained in the guidance for industry on formal meetings with sponsors
and applicants for Prescription Drug User Fee Act (PDUFA) products.

DATES: Submit either electronic or written comments on the collection
of information by July 20, 2015.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA, (44 U.S.C. 3501-3520),
Federal

Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Industry on Formal Meetings With Sponsors and Applicants
for PDUFA Products OMB Control Number 0910-0429--Extension

    This information collection approval request is for FDA guidance on
the procedures for formal meetings between FDA and sponsors or
applicants regarding the development and review of PDUFA products. The
guidance describes procedures for requesting, scheduling, conducting,
and documenting such formal meetings. The guidance provides information
on how the Agency will interpret and apply section 119(a) of the Food
and Drug Administration Modernization Act (FDAMA), specific PDUFA goals
for the management of meetings associated with the review of human drug
applications for PDUFA products, and provisions of existing regulations
describing certain meetings (Sec. Sec.  312.47 and 312.82 (21 CFR
312.47 and 312.82)).
    The guidance describes two collections of information: The
submission of a meeting request containing certain information and the
submission of an information package in advance of the formal meeting.
Agency regulations at Sec. Sec.  312.47(b)(1)(ii), (b)(1)(iv), and
(b)(2) describe information that should be submitted in support of a
request for an end-of-phase 2 meeting and a pre-NDA meeting. The
information collection provisions of Sec.  312.47 have been approved by
OMB control number 0910-0014. However, the guidance provides additional
recommendations for submitting information to FDA in support of a
meeting request. As a result, FDA is submitting additional estimates
for OMB approval.

I. Request for a Meeting

    Under the guidance, a sponsor or applicant interested in meeting
with the Center for Drug Evaluation and Research (CDER) or the Center
for Biologics Evaluation and Research (CBER) should submit a meeting
request to the appropriate FDA component as an amendment to the
underlying application. FDA regulations (Sec. Sec.  312.23, 314.50, and
601.2 (21 CFR 312.23, 314.50, and 601.2)) state that information
provided to the Agency as part of an investigational new drug
application (IND), new drug application (NDA), or biological license
application (BLA) must be submitted with an appropriate cover form.
Form FDA 1571 must accompany submissions under INDs and Form FDA 356h
must accompany submissions under NDAs and BLAs. Both forms have valid
OMB control numbers as follows: Form FDA 1571--OMB control number 0910-
0014 and Form FDA 356h--OMB control number 0910-0338.
    In the guidance document, CDER and CBER ask that a request for a
formal meeting be submitted as an amendment to the application for the
underlying product under the requirements of Sec. Sec.  312.23, 314.50,
and 601.2; therefore, requests should be submitted to the Agency with
the appropriate form attached, either Form FDA 1571 or Form FDA 356h.
The Agency recommends that a request be submitted in this manner for
two reasons: (1) To ensure that each request is kept in the
administrative file with the entire underlying application, and (2) to
ensure that pertinent information about the request is entered into the
appropriate tracking databases. Use of the information in the Agency's
tracking databases enables the Agency to monitor progress on the
activities attendant to scheduling and holding a formal meeting and to
ensure that appropriate steps will be taken in a timely manner.
    Under the guidance, the Agency requests that sponsors and
applicants include in meeting requests certain information about the
proposed meeting. Such information includes:
     Information identifying and describing the product;
     The type of meeting being requested;
     A brief statement of the purpose of the meeting;
     A list of objectives and expected outcomes from the
meeting;
     A preliminary proposed agenda;
     A draft list of questions to be raised at the meeting;
     A list of individuals who will represent the sponsor or
applicant at the meeting;
     A list of Agency staff requested to be in attendance;
     The approximate date that the information package will be
sent to the Agency; and
     Suggested dates and times for the meeting.
    This information will be used by the Agency to determine the
utility of the meeting, to identify Agency staff necessary to discuss
proposed agenda items, and to schedule the meeting.

II. Information Package

    A sponsor or applicant submitting an information package to the
Agency in advance of a formal meeting should provide summary
information relevant to the product and supplementary information
pertaining to any issue raised by the sponsor, applicant, or Agency.
The Agency recommends that information packages generally include:
     Identifying information about the underlying product;
     A brief statement of the purpose of the meeting;
     A list of objectives and expected outcomes of the meeting;
     A proposed agenda for the meeting;
     A list of specific questions to be addressed at the
meeting;
     A summary of clinical data that will be discussed (as
appropriate);
     A summary of preclinical data that will be discussed (as
appropriate); and
     Chemistry, manufacturing, and controls information that
may be discussed (as appropriate).
    The purpose of the information package is to provide Agency staff
the opportunity to adequately prepare for the meeting, including the
review of relevant data concerning the product. Although FDA reviews
similar information in the meeting request, the information package
should provide updated data that reflect the most current and accurate
information available to the sponsor or applicant.

The Agency finds that reviewing such information is critical to
achieving a productive meeting.
    The collection of information described in the guidance reflects
the current and past practice of sponsors and applicants to submit
meeting requests as amendments to INDs, NDAs, and BLAs and to submit
background information prior to a scheduled meeting. Agency regulations
currently permit such requests and recommend the submission of an
information package before an end-of-phase 2 meeting (Sec. Sec.
312.47(b)(1)(ii) and (b)(1)(iv)) and a pre-NDA meeting (Sec.
312.47(b)(2)).
    Description of Respondents: A sponsor or applicant for a drug or
biological product who requests a formal meeting with the Agency
regarding the development and review of a PDUFA product.
    Burden Estimate: Provided in this document is an estimate of the
annual reporting burden for the submission of meeting requests and
information packages under the guidance.

III. Request for a Formal Meeting

    Based on data collected from the review divisions and offices
within CDER and CBER, FDA estimates that approximately 1,099 sponsors
and applicants (respondents) request approximately 2,366 formal
meetings with CDER annually and approximately 175 respondents request
approximately 264 formal meetings with CBER annually regarding the
development and review of a PDUFA product. The hours per response,
which is the estimated number of hours that a respondent would spend
preparing the information to be submitted with a meeting request in
accordance with the guidance, is estimated to be approximately 10
hours. Based on FDA's experience, the Agency expects it will take
respondents this amount of time to gather and copy brief statements
about the product and a description of the purpose and details of the
meeting.

IV. Information Package

    Based on data collected from the review divisions and offices
within CDER and CBER, FDA estimates that approximately 959 respondents
submitted approximately 1,901 information packages to CDER annually and
approximately 142 respondents submitted approximately 193 information
packages to CBER annually prior to a formal meeting regarding the
development and review of a PDUFA product. The hours per response,
which is the estimated number of hours that a respondent would spend
preparing the information package in accordance with the guidance, is
estimated to be approximately 18 hours. Based on FDA's experience, the
Agency expects it will take respondents this amount of time to gather
and copy brief statements about the product, a description of the
details for the anticipated meeting, and data and information that
generally would already have been compiled for submission to the
Agency.
    As stated earlier, the guidance provides information on how the
Agency will interpret and apply section 119(a) of the FDAMA, specific
PDUFA goals for the management of meetings associated with the review
of human drug applications for PDUFA products, and provisions of
existing regulations describing certain meetings (Sec. Sec.  312.47 and
312.82). The information collection provisions in Sec.  312.47
concerning end-of-phase 2 meetings and pre-NDA meetings have been
approved by OMB control number 0910-0014. However, the guidance
provides additional recommendations for submitting information to FDA
in support of a meeting request. As a result, FDA is submitting for OMB
approval these additional estimates.

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
Meeting requests and information     Number of     responses per   Total annual   Average burden    Total hours
            packages                respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Meeting Requests:
    CDER........................           1,099            2.15           2,366              10          23,660
    CBER........................             175            1.51             264              10           2,640
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............          26,300
Information Packages:
    CDER........................             959            1.99           1,901              18          34,218
    CBER........................             142            1.36             193              18           3,474
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............          37,692
                                 ===============================================================================
            Grand Total.........  ..............  ..............  ..............  ..............          63,992
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: May 14, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12170 Filed 5-19-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Pages 30973-30974]
[FR Doc No: 2021-12126]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2021-0002; Internal Agency Docket No. FEMA-B-2129]

Proposed Flood Hazard Determinations; Correction

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice; correction.

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SUMMARY: On May 7, 2021, FEMA published in the Federal Register a
proposed flood hazard determination notice that contained an erroneous
table. This notice provides corrections to that table to be used in
lieu of the erroneous information. The table provided here represents
the proposed flood hazard determinations and communities affected for
Dallas County, Texas and Incorporated Areas.

DATES: Comments are to be submitted on or before September 8, 2021.

ADDRESSES: The Preliminary Flood Insurance Rate Map (FIRM), and where
applicable, the Flood Insurance Study (FIS) report for each community
are available for inspection at both the online location and the
respective Community Map Repository address listed in the table below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
https://msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-2129, to
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance
and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed in the table below, in
accordance with Section 110 of the Flood Disaster Protection Act of
1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own, or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP and are also used to calculate the appropriate
flood insurance premium rates for new buildings built after the FIRM
and FIS report become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP may only be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at https://floodsrp.org/pdfs/srp_fact_sheet.pdf.
    The communities affected by the flood hazard determinations are
provided in the table below. Any request for reconsideration of the
revised flood hazard determinations shown on the Preliminary FIRM and
FIS report that satisfies the data requirements outlined in 44 CFR
67.6(b) is considered an appeal. Comments unrelated to the flood hazard
determinations will also be considered before the FIRM and FIS report
are made final.

Correction

    In the proposed flood hazard determination notice published at 86
FR 24642 in the May 7, 2021, issue of the Federal Register, FEMA
published a table titled ``Dallas County, Texas and Incorporated
Areas''. This table contained inaccurate information as to the
communities affected by the proposed flood hazard determinations
featured in the table. In this document, FEMA is publishing a table
containing the accurate information. The information provided below
should be used in lieu of that previously published.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
               Dallas County, Texas and Incorporated Areas
        Project: 20-06-0070S Preliminary Date: November 13, 2020
------------------------------------------------------------------------
City of Carrollton.....................  Engineering Department, 1945
                                          East Jackson Road, Carrollton,
                                          TX 75006.
City of Cedar Hill.....................  Public Works Department, 285
                                          Uptown Boulevard, Cedar Hill,
                                          TX 75104.
City of Combine........................  City Hall, 123 Davis Road,
                                          Combine, TX 75159.
City of Coppell........................  City Engineering Department,
                                          265 East Parkway Boulevard,
                                          Coppell, TX 75019.
City of Dallas.........................  Dallas Water Utilities,
                                          Stormwater Operations, 320
                                          East Jefferson Boulevard, Room
                                          312, Dallas, TX 75203.
City of Duncanville....................  Public Works Department, 203
                                          East Wheatland Road,
                                          Duncanville, TX 75116.
City of Farmers Branch.................  Public Works Department, 13000
                                          William Dodson Parkway,
                                          Farmers Branch, TX 75234.
City of Grand Prairie..................  Municipal Complex, Stormwater
                                          Department, 300 West Main
                                          Street, Grand Prairie, TX
                                          75050.

City of Hutchins.......................  City Hall, 321 North Main
                                          Street, Hutchins, TX 75141.
City of Irving.........................  Capital Improvement Program
                                          Department, 825 West Irving
                                          Boulevard, Irving, TX 75060.
City of Lancaster......................  Development Services, 700 East
                                          Main Street, Lancaster, TX
                                          75146.
City of Lewisville.....................  Engineering Division, 151 West
                                          Church Street, Lewisville, TX
                                          75057.
City of Mesquite.......................  Engineering Division, 1515
                                          North Galloway Avenue,
                                          Mesquite, TX 75149.
City of Seagoville.....................  City Hall, 702 North Highway
                                          175, Seagoville, TX 75159.
City of University Park................  University Park Community
                                          Development Department, 4420
                                          Worcola Street, Dallas, TX
                                          75206.
City of Wilmer.........................  Public Works Department, 128
                                          North Dallas Avenue, Wilmer,
                                          TX 75172.
Town of Addison........................  Service Center, Public Works
                                          and Engineering, 16801
                                          Westgrove Drive, Addison, TX
                                          75001.
Town of Highland Park..................  Engineering Department, 4700
                                          Drexel Drive, Highland Park,
                                          TX 75205.
Town of Sunnyvale......................  Development Services
                                          Department, 127 North Collins
                                          Road, Sunnyvale, TX 75182.
Unincorporated Areas of Dallas County..  Dallas County Public Works
                                          Department, 411 Elm Street,
                                          4th Floor, Dallas, TX 75202.
------------------------------------------------------------------------

[FR Doc. 2021-12126 Filed 6-9-21; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 88, Number 75 (Wednesday, April 19, 2023)]
[Notices]
[Page 24265]
[FR Doc No: 2023-08282]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2010-0032]

Metro-North Railroad's Request To Amend Its Positive Train
Control Safety Plan and Positive Train Control System

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of availability and request for comments.

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SUMMARY: This document provides the public with notice that, on April
11, 2023, Metro-North Railroad (MNR) submitted a request for amendment
(RFA) to its FRA-approved Positive Train Control Safety Plan (PTCSP).
As this RFA involves a request for FRA's approval of proposed material
modifications to an FRA-certified positive train control (PTC) system,
FRA is publishing this notice and inviting public comment on the
railroad's RFA to its PTCSP. MNR state that this RFA is for an update
to MNR's PTC Onboard Software, release OBC 5.04.000, correcting
existing defects. With the successful completion of Factory and Field
Testing and Supplier Safety Certification, MNR confirms the changes
meet all technical requirements, provide an equivalent or greater level
of safety than the existing PTC System in service, and does not
adversely impact interoperability with tenant railroads.

DATES: FRA will consider comments received by May 9, 2023. FRA may
consider comments received after that date to the extent practicable
and without delaying implementation of valuable or necessary
modifications to a PTC system.

ADDRESSES:
    Comments: Comments may be submitted by going to https://www.regulations.gov and following the online instructions for
submitting comments.
    Instructions: All submissions must include the agency name and the
applicable docket number. The relevant PTC docket number for this host
railroad is Docket No. FRA-2010-0032. For convenience, all active PTC
dockets are hyperlinked on FRA's website at https://railroads.dot.gov/research-development/program-areas/train-control/ptc/railroads-ptc-dockets. All comments received will be posted without change to https://www.regulations.gov; this includes any personal information.

FOR FURTHER INFORMATION CONTACT: Gabe Neal, Staff Director, Signal,
Train Control, and Crossings Division, telephone:<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION: In general, title 49 United States Code
(U.S.C.) section 20157(h) requires FRA to certify that a host
railroad's PTC system complies with title 49 Code of Federal
Regulations (CFR) part 236, subpart I, before the technology may be
operated in revenue service. Before making certain changes to an FRA-
certified PTC system or the associated FRA-approved PTCSP, a host
railroad must submit, and obtain FRA's approval of, an RFA to its PTCSP
under 49 CFR 236.1021.
    Under 49 CFR 236.1021(e), FRA's regulations provide that FRA will
publish a notice in the Federal Register and invite public comment in
accordance with 49 CFR part 211, if an RFA includes a request for
approval of a material modification of a signal and train control
system. Accordingly, this notice informs the public that, on April 11,
2023, MNR submitted an RFA to its PTCSP for its Advanced Civil Speed
Enforcement System II (ACSES II), seeking FRA's approval of a new
software release, Onboard Computer (OBC) 5.04.000 Software Baseline,
and that RFA is available in Docket No. FRA-2010-0032.
    Interested parties are invited to comment on MNR's RFA to its PTCSP
by submitting written comments or data. During FRA's review of this
railroad's RFA, FRA will consider any comments or data submitted within
the timeline specified in this notice and to the extent practicable,
without delaying implementation of valuable or necessary modifications
to a PTC system. See 49 CFR 236.1021; see also 49 CFR 236.1011(e).
Under 49 CFR 236.1021, FRA maintains the authority to approve, approve
with conditions, or deny a railroad's RFA to its PTCSP at FRA's sole
discretion.

Privacy Act Notice

    In accordance with 49 CFR 211.3, FRA solicits comments from the
public to better inform its decisions. DOT posts these comments,
without edit, including any personal information the commenter
provides, to https://www.regulations.gov, as described in the system of
records notice (DOT/ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See https://www.regulations.gov/privacy-notice for the privacy notice of regulations.gov. To facilitate
comment tracking, we encourage commenters to provide their name, or the
name of their organization; however, submission of names is completely
optional. If you wish to provide comments containing proprietary or
confidential information, please contact FRA for alternate submission
instructions.

    Issued in Washington, DC.
Carolyn R. Hayward-Williams,
Director, Office of Railroad Systems and Technology.
[FR Doc. 2023-08282 Filed 4-18-23; 8:45 am]
BILLING CODE 4910-06-P


NCS Herald Cohort Study Instrument # 28 Female Questionnaire 18 Month Home Visit Eligibility: All women who gave birth Mode of administration: Interviewer, home visit 8/ 9/ 2005 Public reporting burden for this collection of information is estimated to average 60 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: Dr. Pauline Mendola, US EPA, MD 58A, Research Triangle Park, NC 27711. E mail: mendola. pauline@ epa. gov. Female 18 Month ( instrument # 28)

1 PRELOADED DATA:

Today's date Language of interview ( English/ Spanish)

Respondent Name Respondent Address and Phone Spouse/ Partner's Name Spouse/ Partner's Address and Phone Biological father's name Marital status Last interview date Student status Employment status Flag for house pets reported Smoking status Chemicals Medications QUESTIONNAIRE: Female 18 Month ( instrument # 28)

2 Pregnancy Status ( Update)

Now I'd like to ask you about your pregnancy status and plans.

1. Are you currently pregnant?

1 YES 2 NO

SKIP TO Q3 3 DON'T KNOW

SKIP TO Q3 2. What is your due date?

MM/ DD/ YYYY DON'T KNOW

What was the first day of your last menstrual period? MM/ DD/ YYYY 3. Which of the following statements best describes your current feelings about becoming pregnant?

1 I am trying to get pregnant now 2 I don't wish to get pregnant now, but I would like to get pregnant within the next three months 3 I would like to get pregnant sometime in the future, but not in the next three months 4 I do not wish to get pregnant again 4. Are you currently sexually active?

1 YES 2 NO

GO TO NEXT MODULE 5. Do you currently use any form of birth control? By birth control, I mean anything that you might have done to prevent pregnancy.

1 YES 2 NO

GO TO NEXT MODULE 6. What form( s) of birth control do you use? ( CODE ALL THAT APPLY)

1 Birth control pills 2 IUD 3 Depo Provera/ Norplant 4 Condoms 5 Rhythm Method 6 Diaphragm 7 Some other method ( SPECIFY) ___________

{ END OF PREGNANCY STATUS MODULE} Female 18 Month ( instrument # 28)

3 Occupation ( Update, revised for post pregnancy)

1. In your last interview on [ FILL DATE], you reported that you were ( FILL: not a / a full time / a parttime student. Is this still correct?

1 YES

SKIP TO Q4 2 NO 2. Are you currently a student full or part time?

1 YES, FULL TIME 2 YES, PART TIME 3 NO, NOT A STUDENT

SKIP TO Q4 3. What type of school are you currently attending?

1 HIGH SCHOOL 2 TECHNICAL SCHOOL 3 COLLEGE OR UNIVERSITY 4 GRADUATE SCHOOL 5 PROFESSIONAL SCHOOL ( FOR EXAMPLE, MEDICAL SCHOOL) 6 OTHER ( SPECIFY)_________________

4. In your last interview on [ FILL DATE], you reported that you were ( FILL EMPLOYMENT). Is this still correct?

1 YES 2 NO

SKIP TO Q5 Q4= YES, STILL WORKING

SKIP TO Q6 Q4= YES, STILL LOOKING FOR WORK GO TO NEXT MODULE Q4= YES, STILL NOT WORKING GO TO NEXT MODULE 5. Are you currently

[ ONLY DISPLAY THE OPTIONS NOT SELECTED IN PREVIOUS INTERVIEW] 1 Working at a job or business,

SKIP TO PARAGRAPH BEFORE Q7 2 Looking for work, or

GO TO NEXT MODULE 3 Not working at a job or business?

GO TO NEXT MODULE 6. Did you start work at any new jobs since [ FILL DATE]?

1 YES 2 NO

GO TO NEXT MODULE Please tell me about the jobs you've had since your last interview, starting with the ( FILL: current/ most recent/ next) one.

7. On what date did you start this job?

MM/ DD/ YYYY Female 18 Month ( instrument # 28)

4 8. On what date did you stop working at this job?

MM/ DD/ YYYY 1 = STILL EMPLOYED 9. What kind of business or industry ( FILL: is/ was) this? ( For example: TV and radio management, retail shoe store, state labor department, farm.)

_________________________________ ENTER NAME OF BUSINESS, JOB, OR INDUSTRY 10. What kind of work ( FILL: are/ were) you doing? ( For example: farming, mail clerk, computer specialist.)

_________________________________ ENTER NAME OF OCCUPATION 11. How many hours a week ( FILL: do/ did) you usually work at this job?

____ HOURS 12. ( FILL: Do/ Did) you do shift work for this job?

1 YES 2 NO

SKIP TO Q14 13. ( FILL: Does/ Did) this include the night shift?

1 YES 2 NO 14. Did you have any other jobs since [ FILL DATE]?

1 YES [ REPEAT Q7 Q13 FOR UP TO 3 JOBS] 2 NO

GO TO Q15 15. Are you currently on paid or unpaid maternity leave from any job?

1 YES, PAID LEAVE 2 YES, UNPAID LEAVE 3 BACK AT WORK

SKIP TO Q17 16. When do you intend to return to work? Would you say

1 Within one month 2 Between 1 and 3 months 3 Between 4 and 6 months 4 More than 6 months Female 18 Month ( instrument # 28)

5 17. [ IF BACK AT WORK, ASK] What type of early childhood education program or other child care does your child participate in while you are at work? [ IF NOT BACK AT WORK, ASK] What plans do you have for the care of your child when you go back to work? [ IF R DOES NOT WORK, ASK] Do you have any usual arrangements for the care of your child?

1 EMPLOYER SPONSORED EARLY CHILDHOOD EDUCATION PROGRAMS OR CHILD CARE 2 OTHER EARLY CHILDHOLD EDUCATION PROGRAMS OR CHILD CARE 3 CARE PROVIDED BY FAMILY MEMBER 4 CARE PROVIDED BY FRIEND 5 OTHER ( SPECIFY)__________

18. How many hours per week does your child spend in [ INSERT ANSWER FROM Q5]? ____ hours Female 18 Month ( instrument # 28)

6 Chemical Exposures ( Update)

Now I'm going to ask you about chemicals you may have used at work, at home, or for any hobbies.

1. Last time you said you were { FILL: not exposed to any of these chemicals / exposed to [ DISPLAY LIST OF EXPOSURES REPORTED IN PREVIOUS VISIT]}. Is this still correct? ( HAND SHOW CARD TO RESPONDENT AND READ THE LETTER CORRESPONDING TO EACH PREVIOUS EXPOSURE)

1 YES

IF NO PREVIOUS EXPOSURES, SKIP TO END 2 NO 2. [ IF Q1= 1, ASK:] Are you currently also exposed to any of the following chemicals? [ IF Q1= 2, ASK:] Which of the following chemicals are you currently exposed to?

[ IF Q1= 1, DISPLAY ONLY THOSE EXPOSURES NOT PREVIOUSLY REPORTED. IF Q1= 2, DISPLAY ALL EXPOSURES]

YES NO

SKIP TO NEXT EXPOSURE 3. How often are you exposed to [ INSERT EXPOSURE] ? Would you say. . .

4. Did the exposure occur while you were at work?

2. Currently Exposed Yes = 01 No = 02 3. Frequency 1 = Daily 2 = 2 3/ week 3 = 1/ week 4 = 1/ month 5 = < 1/ month 4. At work Yes = 01 No = 02 A. Fuels, solvents, dry cleaning fluids, degreasers, or adhesives B. Lead, including paints with lead in them C. Fumes or gases ( e. g., nitrous oxide, ethylene oxide, anesthetic gases) D. Radiation ( e. g., fluoroscopy, radioisotopes, highintensity microwaves, x rays) E. Mercury F. Metal fumes or particles G. Pesticides that you've mixed or applied H. Paints, strippers, or varnishes I. Hair and nail products ( e. g, hair dye, bleach, hair relaxer, nail polish and remover) J. Cleaning products ( e. g., oven cleaner, disinfectant, carpet cleaner, bleach) K. Carbon black from copying machines L. Coal or coal products from hot asphalt, tar, or roofing material { END OF CHEMICAL EXPOSURES MODULE} Female 18 Month ( instrument # 28)

7 Home Environment/ Conditions ( Update) [ If Instrument # 29 has been administered Go To Next Module]

Pesticides and Lawn Care Now I'm going to ask you about the use of pesticides and lawn treatments in and around your home.

1. In the past 6 months, were any chemicals used inside this residence for the control of termites, insects, rodents, or other pests?

1 YES 2 NO

SKIP TO Q6 2. In the past 6 months, what rooms in your home were treated with products for the control of termites, insects, rodents, or other pests? ( CODE ALL THAT APPLY)

1 Living room 2 Family room 3 Dining room 4 Kitchen 5 Bathroom( s) 6 Bedroom( s) 7 Other rooms 3. In the past 6 months, how many times....

a. did a professional exterminator apply these products inside this residence? _______

b. did you apply these products inside this residence? _______

4. In what month were they last used inside this residence?

_____

5. What were the names of the products last used inside this residence?

_________________ _________________ _________________

6. In the past 6 months, were any chemicals used outside this residence for the control of termites, insects, rodents, or other pests?

1 YES 2 NO

SKIP TO Q10 7. In the past 6 months, how many times.... Female 18 Month ( instrument # 28)

8 a. did a professional exterminator apply these products outside this residence? _______

b. did you apply these products outside this residence? _______

8. In what month were they last used outside this residence?

_____

9. What were the names of the products last used outside this residence?

_________________ _________________ _________________

10. In the past 6 months, have you had any regular lawn or yard treatments?

1 YES 2 NO

GO TO NEXT SECTION 11. Who usually applies these treatments?

1 You, 2 A professional, or 3 Someone else?

The next few questions are about the general condition of your home.

Renovations and Paint 1. In the last 6 months, which of the following renovations have been performed in this home? ( CODE ALL THAT APPLY)

1 Adding a room? 2 Putting up or taking down a wall? 3 Replacing windows? 4 Refinishing floors? 5 Exterior painting? 6 Interior painting 2. Over the last 6 months, how would you rate the typical condition of the painted surfaces   the walls, trim, etc.   inside this residence? Would you say

1 Excellent, 2 Very good, 3 Fair, or 4 Poor?

Water Damage / Mold Female 18 Month ( instrument # 28)

9 1. Water damage includes water stains on the ceiling or walls, rotting wood, and flaking sheetrock or plaster. This damage may be from broken pipes, a leaky roof or floods. Have you seen any water damage in your home?

1 YES 2 NO 2. Have you seen any mold or mildew on walls or other surfaces other than food, inside your home?

1 YES 2 NO

GO TO NEXT MODULE 3. In which rooms have you seen the mold or mildew? ( CODE ALL THAT APPLY)

1 Kitchen 2 Living room 3 Hall/ landing 4 Your bedroom 5 Other bedrooms 6 Bathroom/ toilet { END OF HOME ENVIRONMENT MODULE} Female 18 Month ( instrument # 28)

10 Medical History   Child 18 month The next questions are about your child's general health.

1. Has your child had any of the following illnesses or problems since our last interview on { FILL DATE}? ( CODE ALL THAT APPLY)

1 Fever 2 Diarrhea 3 Vomiting 4 Ear infection 5 Runny nose or cold 6 Cough or wheeze 7 Respiratory Syncytial Virus ( RSV) 8 Food allergy 9 Eczema ( atopic dermatitis) 10 Asthma 11 Weight loss or poor weight gain 12 Vision problems 13 Seizure 2. [ ASK IF Q1= 13] Was your child's seizure related to a high fever?

1 YES 2 NO [ SKIP TO Q7 IF Q1 NOT = 8]

3. Has your child been diagnosed as having an allergy to any food?

1 YES 2 NO

SKIP TO Q7 4. What method was used to test for food allergy? ( CODE ALL THAT APPLY)

1 A skin test 2 A blood test 3 Food elimination ( withdrawal of the specific food to see if symptoms disappeared) 4 Food challenge ( introduction of a specific food to see if symptoms reappeared) 5 Based on your description of symptoms 6 Other ( specify)_____________________

5. How old was your child the first time he or she was diagnosed has having a food allergy?

__________ MONTHS AND _________ WEEKS 6. Which of the following treatments has your baby had for problems with food? ( CODE ALL THAT APPLY)

1 Non prescription medicine 2 Prescription medicine 3 Treatment in a doctor's office or emergency room 4 Admitted to a hospital Female 18 Month ( instrument # 28)

11 7. Since your last interview on { FILL DATE}, has your child had wheezing or whistling in the chest?

1 YES 2 NO

SKIP TO Q9 8. How many attacks of wheezing has your child had since { FILL DATE}?

1 NONE 2 1 TO 3 3 4 TO 12 4 MORE THAN 12 9. Since your last interview, has your child had a dry cough at night, apart from a cough associated with a cold or chest infection?

1 YES 2 NO

SKIP TO Q12 10. Has your child had a problem with sneezing or a runny or blocked nose when { he/ she} DID NOT have a cold or flu?

1 YES 2 NO 11. Since your last interview on { FILL DATE}, has this nose problem been accompanied by itchy watery eyes?

1 YES 2 NO 12. Since your last interview, has { he/ she} been hospitalized for any reason or has your baby been taken to a hospital for any outpatient procedure or surgery?

1 YES 2 NO

SKIP TO Q14 13. How many nights was your child in the hospital for the most recent problem? ( WRITE 0 IF BABY DID NOT STAY OVERNIGHT)

___________ NIGHTS 14. Has your child been diagnosed with any severe, long term medical problems since { FILL DATE}?

1 YES 2 NO

GO TO NEXT MODULE 14a. What medical problems?

__________________________________ Female 18 Month ( instrument # 28)

12 15. How would you describe { FILL NAME}' s health now?

1 Excellent 2 Good 3 Fair 4 Poor 16 Has your child seen the doctor for at least one well visit since your last interview?

1 YES 2 NO { END OF CHILD HEALTH MODULE} Female 18 Month ( instrument # 28)

13 Developmental/ Sleep ( 18 month)

1. Now I'm going to ask you some questions about [ child]' s activities and development. This list probably includes some skills that [ child] has already learned, and some that he/ she can't do yet. For each question, you can answer " yes" if this is an activity that [ child] does regularly; " sometimes" if it's an activity that [ child] is learning how to do; and " not yet" if it's something that he/ she hasn't yet learned. If you're not sure, then we'll try it out and see if [ child] can do it. You can follow along by looking at this paper; some of the questions have pictures showing the activity.

YES SOMETIMES NOT YET Communication Questions When your baby wants something, does she tell you by pointing to it? 1 2 0 Does your child point to, pat, or try to pick up pictures in a book? 1 2 0 When you ask, " Where is the ball ( hat, shoe, etc.)?" does your baby look at the object? Make sure the object is present. Check " yes" if he knows one object. 1 2 0 When you ask her to, does your child go into another room to find a familiar toy or object? You might ask, " Where is your ball?" or say, " Bring me your coat," or " Go get your blanket." 1 2 0 Does your child imitate a two word sentence? For example, when you say a two word phrase such as " Mama eat," " Daddy play," " Go home, " or " What's this?" does your child say both words back to you? ( Check " yes" even if her words are difficult to understand.) 1 2 0 Does your child say eight or more words in addition to " Mama" and " Dada"? 1 2 0 Does your child say two or three words that represent different ideas together, such as " See dog," " Mommy come home," or " Kitty gone"? ( Don't count word combinations that express one idea, such as " Byebye " All gone," " All right," and " What's that?") Please give an example of your child's word combinations: 1 2 0 Gross Motor Questions Does your child climb onto furniture? 1 2 0 Does your child bend over or squat to pick up an object from the floor and then stand up again without any support? 1 2 0 Does your child move around by walking, rather than by crawling on his hands and knees? 1 2 0 Does your child walk well and seldom fall? 1 2 0 Does your child climb on an object such as a chair to reach something she wants? 1 2 0 Does your child walk down stairs if you hold onto one of her hands? 1 2 0 When you show him how to kick a large ball, does your child try to kick the ball by moving his leg forward or by walking into it? ( If your child already kicks a ball, check " yes" for this item.) 1 2 0 Fine Motor Questions Does your baby throw a small ball with a forward arm motion? ( If he simply drops the ball, check ` not yet' for this item.) 1 2 0 Does your baby help turn the pages of a book? ( You may lift a page for her to grasp.) 1 2 0 Female 18 Month ( instrument # 28)

14 Does your child stack a small block or toy on top of another one? 1 2 0 Does your child stack three small blocks or toys on top of each other by herself? 1 2 0 Does your child make a mark on the paper with the tip of a crayon ( or pencil or pen) when trying to draw? 1 2 0 Does your child turn the pages of a book by himself? He may turn more than one page at a time. 1 2 0 Does your child get a spoon into her mouth right side up so that the food usually doesn't spill? 1 2 0 Problem Solving Questions Does your child drop several ( six or more) small toys into a container, such as a box or bowl? ( You may show him how to do it.) 1 2 0 After you have shown her how, does your child try to get a toy that is slightly out of reach by using a spoon, stick, or similar tool? 1 2 0 Without first showing him how, does your child scribble back and forth when you give him a crayon ( or pencil or pen)? 1 2 0 After a crumb or Cheerio is dropped into a bottle, does your child turn the bottle upside down to dump it out again? ( You may show her how.) 1 2 0 After he watches you draw a line from the top of the paper to the bottom with a crayon ( or pencil or pen), does your child copy you by drawing a single line on the paper in any direction? ( Scribbling back and forth does not count as " yes".) 1 2 0 After a crumb or Cheerio is dropped into a small, clear bottle, does your child turn the bottle upside down to dump out the crumb or Cheerio? ( Do not show her how.) 1 2 0 Personal Social Questions Does your baby play with a doll or stuffed toy by hugging it? 1 2 0 While looking at himself in the mirror, does your child offer a toy to his own image? 1 2 0 Does your child get your attention or try to show you something by pulling on your hand or clothes? 1 2 0 Does your child come to you when she needs help, such as with winding up a toy? 1 2 0 Does your child drink from a cup or glass, setting it down again with little spilling? 1 2 0 Does your child copy activities you do, such as wipe up a spill, sweep, shave, or comb hair? 1 2 0 2. Overall, would you describe your baby as

Yes No a. Calm? 1 2 b. Worried? 1 2 c. Sociable or outgoing? 1 2 d. Angry? 1 2 e. Shy or quiet? 1 2 Female 18 Month ( instrument # 28)

15 f. Stubborn? 1 2 g. Happy? 1 2 3. How often do you do following activities with your baby?

Never Occasionally Almost Everyday Every day Play with toys? 0 1 2 3 Watch TV? 0 1 2 3 Read or look at books? 0 1 2 3 Go for walks? 0 1 2 3 Attend baby activity classes such as Mommy and me, Baby Gymboree, swimming classes? 0 1 2 3 Play outside? 0 1 2 3 4. How much TV does your child watch on an average day?

1 Less than 1 hour 2 1   3 hours 3 4   6 hours 4 More than 6 hours 5. When your child watches TV, does { he/ she} usually watch

1 Educational videos such as Baby Einstein 2 Recreational videos 3 Children's television programming 4 Regular television programs Now I'll ask you about your baby's sleeping.

6. In what position do you most often lay your baby down for naps?

1 Side 2 Stomach 3 Back 7. In what position do you most often lay your baby down to sleep at night?

1 Side 2 Stomach 3 Back 8. Does your baby usually sleep in your room or in a different room at night?

1 IN YOUR ROOM 2 IN A DIFFERENT ROOM Female 18 Month ( instrument # 28)

16 9. What does your baby usually sleep in at night?

1 Crib 2 Co sleeper ( attaches to the side of your bed) 3 In bed or other place with you 4 In his/ her own bed { END OF DEVELOPMENTAL MODULE} Female 18 Month ( instrument # 28)

17 Child Diet 18 Months The next questions are about feeding your child.

1. In the past 7 days, how often was your child fed each item listed below? Include feedings by everyone who feeds the child and include snacks and night time feedings.

FEEDINGS PER DAY Breast milk ........................................................................................... _______

Formula................................................................................................ _______ Cow's milk........................................................................................... _______ Other milk: soy milk, rice milk, goat milk ............................................. _______ Other dairy foods: Yogurt, cheese, ice cream, pudding, etc. ................... _______ Other soy foods: tofu, frozen soy desserts, etc....................................... _______ 100% fruit or 100% vegetable juice....................................................... _______

Sweet drinks ( juice drinks, soft drinks, soda, pop, Kool Aid, Sunny D, etc.) .............................................................................................. _______

Baby cereal........................................................................................... _______ Other cereals and starches: breakfast cereals, teething biscuits, crackers, breads, pasta, rice, etc.......................................................... _______

Fruit ..................................................................................................... _______ Vegetables ............................................................................................ _______ Meat, chicken, combination dinners ...................................................... _______

Fish or shellfish .................................................................................... _______ Peanut butter, other peanut foods, or nuts .............................................. _______ Eggs ..................................................................................................... _______ Sweet foods: candy, cookies, cake, etc................................................... _______ Fast foods ............................................................................................. _______

2. When eating does your child

Yes No Eat/ drink quickly 1 2 Eat/ drink slowly 1 2 Seem to be fussy or choosy about food/ breast milk/ formula 1 2 Seem satisfied when finished 1 2 Seem hungry when finished 1 2 [ SKIP TO Q8 IF ` 0' ENTERED FOR FORMULA IN Q1]

3. How often does your baby drink all of his or her bottle of formula?

1 Always 2 Most of the time 3 Sometimes 4 Rarely Female 18 Month ( instrument # 28)

18 5 Never 4. In the past 7 days, on the average, how many ounces of formula did your baby drink at each feeding?

_______ oz 5. How often is your baby encouraged to finish a bottle if he or she stops drinking before the formula is all gone?

1 Always 2 Most of the time 3 Sometimes 4 Rarely 5 Never 6. Which brand of infant formula was fed to your baby in the past 7 days? Please tell me the group number for each infant formula your baby was fed. ( INTERVIEWER: USE SHOW CARD)

1 Group 1 2 Group 2 3 Group 3 4 Group 4 5 Group 5 6 Group 6 7. What type of infant formula is it? ( CODE ALL THAT APPLY)

1 Ready to feed 2 Liquid concentrate 3 Powder   from can that makes more than one bottle 4 Powder   from single serving packs [ SKIP TO Q14 IF ` 0' FOR BREASTMILK IN Q1]

8. Does your baby usually feed from both breasts at each feeding?

1 YES 2 NO 3 BABY IS FED ONLY PUMPED MILK

SKIP TO Q10 9. Does your baby usually let go of the breast him or herself when finished feeding?

1 YES, BOTH BREASTS 2 YES, FIRST BREAST ONLY 3 YES, SECOND BREAST ONLY 4 NO Female 18 Month ( instrument # 28)

19 10. In an average 24 hour period, what is the LONGEST time for you, the mother, between breastfeedings or expressing milk, that is, from the start of one breastfeeding or expressing session to the start of the next? Please think of time between feedings during both night and day to find the longest time. ( WRITE IN THE NUMBER OF HOURS AND MINUTES)

______ HOURS ________ MINUTES 11. How many times in the past 7 days has your baby been given expressed or pumped breast milk to drink?

______ TIMES [ IF ` 0', SKIP TO Q14]

12. How often does your baby drink all of his or her cup or bottle of expressed milk?

1 Always 2 Most of the time 3 Sometimes 4 Rarely 5 Never 13. How often is your baby encouraged to finish a cup or bottle if he or she stops drinking before the expressed breast milk is all gone?

1 Always 2 Most of the time 3 Sometimes 4 Rarely 5 Never [ IF BABY IS NOT FED ANY FOODS OR DRINKS BESIDES BREAST MILK OR FORMULA, GO TO NEXT MODULE]

[ SKIP TO Q17 IF ` 0' ENTERED FOR COW'S OR OTHER MILK IN Q1]

14. How often does your baby drink all of his or her bottle of cow's other ( soy, rice, or goat) milk?

1 Always 2 Most of the time 3 Sometimes 4 Rarely 5 Never 15. In the past 7 days, on the average, how many ounces of cow's or other ( soy, rice, or goat) milk did your baby drink at each feeding?

_______ oz 16. How often is your baby encouraged to finish a bottle if he or she stops drinking before the cow's or other ( soy, rice, or goat) milk is all gone? Female 18 Month ( instrument # 28)

20 1 Always 2 Most of the time 3 Sometimes 4 Rarely 5 Never [ IF BABY IS NOT FED ANY FOODS OR DRINKS BESIDES BREAST MILK, COW'S MILK OR FORMULA, GO TO NEXT MODULE]

17. For each food category listed below, was most of the food fed to the child over the past 7 days commercial baby food? Commercial baby foods are those sold especially for babies. Foods that are not commercial baby foods include fresh fruit, fruit juices other than those especially sold for babies, foods you prepare especially for the baby, and table food.

YES NO Fruit and vegetable juice 1 2 Fruit 1 2 Vegetables 1 2 Meat, chicken, combination dinners, etc 1 2 Female 18 Month ( instrument # 28)

21 18. Is any of the food you feed to your child organic, or pesticide free?

1 YES 2 NO 19. Which of the following supplements was your child given at least three days a week during the past 2 weeks? If your baby was given a supplement containing more than one of the items listed, mark each of the separate items. ( CODE ALL THAT APPLY)

1 Fluoride 2 Iron 3 Vitamin D 4 Other vitamins { END OF 18 MONTH CHILD DIET MODULE} Female 18 Month ( instrument # 28)

22 Personal Medical History ( Update, revised for post pregnancy)

The next few questions are about changes to your general health.

1. Since your last interview on [ FILL DATE], have you developed any of the following health problems? ( CODE ALL THAT APPLY)

[ CAPI: ONLY DISPLAY ITEMS = NO FOR LAST INTERVIEW]

1 High blood pressure or hypertension 2 High blood sugar or diabetes 3 High cholesterol 4 Anemia ( poor blood, low iron) 5 Heart problems 6 Hayfever or allergy 7 Skin allergy or eczema 8 Asthma IF Q1 = 8, ASK Q2 4 ELSE, SKIP TO Q5 2. Did a doctor or other medical provider tell you that you have asthma?

1 YES 2 NO

SKIP TO Q5 3. Have you used any inhalers or taken any pills for asthma or wheezing or whistling in your chest?

1 YES 2 NO 4. Have you ever gone to an emergency room or stayed overnight in a hospital for your asthma?

1 YES 2 NO 5. Since your last interview on [ FILL DATE], have you been diagnosed with any other serious illnesses that I haven't asked about?

1 YES 2 NO

GO TO NEXT MODULE 5a. What were those illnesses? ( ENTER VERBATIM)

_______________________

6. Since [ FILL DATE], have you been hospitalized for any reason?

1 YES 2 NO

GO TO NEXT MODULE Female 18 Month ( instrument # 28)

23 6a. Why were you hospitalized? ( ENTER VERBATIM)

__________________________

{ END OF PERSONAL MEDICAL HISTORY MODULE} Female 18 Month ( instrument # 28)

24 Activity ( Full)

Now I am going to ask you some questions about physical activities you might do at work, at home, for recreation, and about activities involving child or adult care. I want you to tell me about activities you did in the past month that caused at least some increase in breathing and heart rate.

1. In the past month, did you  2. IF YES: On average over the past month, how many times did you do these activities? Would you say  3. Thinking about your breathing and heart rate, how hard did this usually feel to you? Did it feel  ( HAND SHOW CARD TO RESPONDENT) A. [ SKIP IF NOT CURRENTLY EMPLOYED] participate in any work activities, such as walking, lifting, or carrying objects or people, that caused at least some increase in breathing and heart rate? 1 = Daily, 2 = 2 to 3 times per week, 3 = Once a week, or 4 = Once a month? FH SH H B. participate in any non work, recreational activity or exercise, such as walking for exercise, swimming, or dancing, that caused at least some increase in breathing and heart rate? 1 = Daily, 2 = 2 to 3 times per week, 3 = Once a week, or 4 = Once a month? FH SH H C. participate in any outdoor household activities, such as gardening, mowing, or raking, [ that caused at least some increase in breathing and heart rate]? 1 = Daily, 2 = 2 to 3 times per week, 3 = Once a week, or 4 = Once a month? FH SH H D. participate in any indoor household activities, such as scrubbing floors, mopping, laundry, or vacuuming, [ that caused at least some increase in breathing and heart rate]? 1 = Daily, 2 = 2 to 3 times per week, 3 = Once a week, or 4 = Once a month? FH SH H E. participate in any child or adult care activities that caused at least some increase in breathing and heart rate? These would be activities such as playing with children, pushing a stroller or wheelchair, carrying, or lifting a child or adult. 1 = Daily, 2 = 2 to 3 times per week, 3 = Once a week, or 4 = Once a month? FH SH H F. walk for transportation, such as to work or to the store, and that walking caused at least some increase in breathing and heart rate? 1 = Daily, 2 = 2 to 3 times per week, 3 = Once a week, or 4 = Once a month? FH SH H G. bike for transportation, such as to work or to the store, and that biking caused at least some increase in breathing and heart rate? 1 = Daily, 2 = 2 to 3 times per week, 3 = Once a week, or 4 = Once a month? FH SH H FH = Fairly hard ( at least some increase in breathing and heart rate), SH = Somewhat hard ( moderate increase in breathing and heart rate), or H = Hard or very hard ( large increase in breathing and heart rate)? Female 18 Month ( instrument # 28)

25 Now think about the activities you did in the past week

4. [ SKIP IF NOT CURRENTLY EMPLOYED] In the past week, would you say your work activities were usually

1 Not hard = did not feel any increase in breathing or heart rate 2 Fairly light = at least some increase in breathing and heart rate 3 Somewhat hard = moderate increase in breathing and heart rate 4 Hard or very hard = large increase in breathing and heart rate 5. Think about how active you were during your non working and recreational hours in the past week. Would you say your activities were usually

1 not hard = you did not feel any increase in breathing or heart rate 2 fairly light = you had at least some increase in breathing and heart rate 3 somewhat hard = you had a moderate increase in breathing and heart rate 4 hard or very hard = you had a large increase in breathing and heart rate Now I will ask you to think about your typical daily activities during the past month.

6. Please tell me which of these four sentences best describes your usual daily activities over the past month? ( INTERVIEWER PROBE: Daily activities may include your work, housework, errands, and anything else you normally do throughout a typical day.)

1 You sit during the day and do not walk about very much 2 You stand or walk about quite a lot during the day, but do not have to carry or lift things very often 3 You lift or carry light loads, or have to climb stairs or hills often 4 You do heavy work or carry heavy loads 7. Over the past month, on a typical day how much time altogether did you spend sitting and watching TV or videos or using a computer outside of work? Would you say . . .

0 Less than 1 hour 1 1 hour 2 2 hours 3 3 hours 4 4 hours 5 5 hours or more 6 You do not watch TV or videos or use a computer outside of work 8. How does the amount of activity that you reported for the past month compare with your physical activity six months ago? Over the past month, were you . . .

1 More active 2 Less active 3 About the same { END OF ACTIVITY MODULE} Female 18 Month ( instrument # 28)

26 Neighborhood ( Full) If Instrument # 29 has been administered Go To Next Module]

Now I'd like to ask you about the neighborhood you live in.

1. In your opinion, is your neighborhood

1 A very good place to live 2 A fairly good place to live 3 Not a very good place to live, or 4 Not at all a good place to live?

2. How often do people in your neighborhood

Never Rarely Sometimes Often Always DK a. Visit your home? 0 1 2 3 4  1 b. Argue with you? 0 1 2 3 4  1 c. Look after your children? 0 1 2 3 4  1 d. Keep to themselves? 0 1 2 3 4  1 e. Attend religious services? 0 1 2 3 4  1 3. Is your neighborhood

Not at all Sometimes Usually a. Lively? 0 1 2 b. Polluted/ dirty? 0 1 2 c. Friendly? 0 1 2 d. Noisy? 0 1 2 e. Clean? 0 1 2 f. Attractive? 0 1 2 4. Have you ever asked a neighbor  ( CODE ALL THAT APPLY)

1. To help with minor household tasks or repairs? 2. To give you a ride somewhere? 3. To help take care of you or a family member when you are sick? 4. To borrow money? 5. To borrow other items such as food or tools?

5. Do you feel that your neighborhood is

1 Very safe 2 Somewhat safe 3 Somewhat unsafe, or 4 Very unsafe?

6. In your opinion, does your neighborhood have problems with  ( CODE ALL THAT APPLY)

a. Property crimes such as break ins or burglaries? b. Personal crimes such as muggings or beatings? c. Violent crimes? d. Drug dealing? Female 18 Month ( instrument # 28)

27 7. From where you live, is it relatively easy for you to get to  ( CODE ALL THAT APPLY)

a. stores to get the groceries you need? b. public parks or recreational facilities? c. doctor's offices or clinics? d. your religious institution? e. your children's schools? f. daycare programs?

8. Are you a member of any religious faith?

1 YES 2 NO

GO TO NEXT MODULE 9. How often do you go to a place of worship?

1 At least once a week 2 At least once a month 3 At least once a year 4 Or not at all?

{ END OF NEIGHBORHOOD MODULE} Female 18 Month ( instrument # 28)

28 Demographics ( Income)

Household income is often used in scientific studies to compare groups of people who are similar. We do some analysis of the data using these groups. Please remember that all the data you provide is held in strict confidence.

1. Do you or your household receive income from ? ( INTERVIEWER: USE SHOW CARD. CODE ALL THAT APPLY)

a. Wages and salaries? b. Self employment, including business and farm income? c. Family or friends? d. Aid such as Temporary Assistance for Needy Families ( TANF), welfare, WIC, public assistance, general assistance, food stamps, or Supplemental Security Income? e. [ Do you or your household receive income from] Interest bearing checking accounts, savings accounts, IRAs or certificates of deposit, money market funds, treasury notes, bonds, or other investments that earned interest? f. Dividends received from stocks or mutual funds, or net rental income from property, royalties, estates or trusts? g. Unemployment benefits? h. Child support or alimony? i. Social security, Railroad Retirement, workers' compensation, disability, veteran benefits, or pensions? j. Any other source? SPECIFY____________________

2. Including all sources of income just mentioned, approximately what is the gross annual income for all members in this household? ( INTERVIEWER: USE SHOW CARD)

1 Less than $ 9,999, 2 $ 10,000  $ 19,999, 3 $ 20,000  $ 29,999, 4 $ 30,000  $ 39,999, 5 $ 40,000  $ 49,999, 6 $ 50,000  $ 74,999, 7 $ 75,000  $ 99,999, or 8 $ 100,000 or more?

3. How many adults depend on this income?

______

4. How many children depend on this income?

______

5. Do you own this house/ apartment, or is it being rented or occupied through some other arrangement?

1 OWN OR BEING BOUGHT 2 RENT 3 OTHER ARRANGEMENT Female 18 Month ( instrument # 28)

29 6. Do you { FILL: or your spouse/ partner} have any money in savings or checking accounts or other investment accounts? ( INTERVIEWER: IF NECESSARY READ: Please think ONLY about these types of savings for this question.)

1 YES 2 NO 7. Do you { FILL: or your spouse/ partner} have any money in individual retirement accounts such as IRAs or Keoghs? ( INTERVIEWER: IF NECESSARY READ: Please think only about these types of savings for this question, and DO NOT REPORT any savings already reported.)

1 YES 2 NO { END OF DEMOGRAPHICS/ INCOME MODULE} Female 18 Month ( instrument # 28)

30 Alcohol ( update)

The next few questions are about alcohol consumption. A " drink" is a can or bottle of beer, a glass of wine or a wine cooler, a shot of liquor, or a mixed drink with liquor in it. We are not asking about times when you only had a sip or two from a drink.

1. Since your last interview on [ FILL DATE], have you had any alcoholic drinks?

1 YES 2 NO

GO TO NEXT MODULE 2. Since your last interview on [ FILL DATE], how many alcoholic drinks did you have in an average week? Would you say

1 Less than 1 drink a week, 2 1 to 3 drinks a week, 3 4 to 6 drinks a week, 4 7 to 13 drinks a week, or 5 14 drinks or more a week?

3. Since your last interview on [ FILL DATE], how many times did you drink 5 alcoholic drinks or more in one sitting? Would you say

1 Never, 2 1 time, 3 2 or 3 times, 4 4 or 5 times, or 5 6 or more times?

{ END OF ALCOHOL MODULE} Female 18 Month ( instrument # 28)

31 Tobacco ( update, revised for post pregnancy)

These next questions are about your use of tobacco products. This includes cigarettes, chewing tobacco, snuff, cigars, and pipe tobacco.

1. Since your last interview on [ FILL DATE], have you used snuff, dip, or chewing tobacco, even once?

1 YES 2 NO 2. Since your last interview, have you smoked a cigar or tobacco pipe, even once?

1 YES 2 NO

SKIP TO Q3 2a. How often have you smoked cigars or tobacco pipes since your last interview?

_____ NUMBER OF TIMES ENTER UNIT 1 DAY 2 WEEK 3 MONTH [ IF SMOKER FROM PREVIOUS INTERVIEW, ASK Q3 Q4 ] [ IF NON SMOKER IN PREVIOUS INTERVIEW, SKIP TO Q5 ] 3. Do you still smoke cigarettes?

1 YES

SKIP TO Q6 2 NO 4. When did you stop smoking?

MM/ YYYY

SKIP TO Q7 5. In your last interview you reported that you were not smoking cigarettes. Are you currently smoking cigarettes now?

1 YES 2 NO

SKIP TO Q7 6. How many cigarettes do you smoke on an average day now? Would you say

1 Less than 1 cigarette per day, 2 1 to 5 cigarettes, 3 6 to 10 cigarettes, 4 11 to 20 cigarettes, 5 21 to 40 cigarettes, or 6 41 cigarettes or more? Female 18 Month ( instrument # 28)

32 7. In your last interview on [ FILL DATE], you reported that there were [ FILL #] cigarette smokers who lived in your home not including yourself. Is this still correct?

1 YES

SKIP TO Q9 2 NO 8. Not including yourself, how many cigarette smokers live in your home now?

_____

9. About how many hours per day are you in the same room with someone who is smoking cigarettes, cigars, or tobacco pipes?

_____ Hours 999 Less than 1 hour a day 10. About how many hours per day is your child in the same room with someone who is smoking cigarettes, cigars, or tobacco pipes?

_____ Hours 000 None 999 Less than 1 hour a day 11. Which of the following statements describes the rules about smoking inside your home now?

1 No one is allowed to smoke anywhere inside my home. 2 Smoking is allowed in some rooms or at some times. 3 Smoking is permitted anywhere inside my home.

{ END OF TOBACCO MODULE} Female 18 Month ( instrument # 28)

33 Acceptability ( To be administered at the end of the home visit)

This study will be able to answer health questions best if we are able to keep people involved in the study. To do this, we would like to get some feedback from you about the study overall and this visit today to help improve the study in the future.

1. Was participating in the visit today convenient for you?

1 YES

SKIP TO Q6 2 NO 2. Did you have to take time off from work to have this interview today?

1 YES 2 NO 3. Did you need to find childcare to have this interview today?

1 YES 2 NO 4. Were there any other major obstacles for you to have this interview today?

1 YES 2 NO

SKIP TO Q6 5. What were they? ( ENTER VERBATIM)

____________________________

6. Why did you decide to participate in this study? ( CODE ALL THAT APPLY)

1 THE STUDY WOULD BENEFIT MYSELF OR MY CHILD 2 CONTRIBUTE TO IMPROVE HEALTH OF CHILDREN AND PREGNANT WOMEN IN THE FUTURE 3 INTERESTING PROJECT TO BE INVOLVED IN 4 CURIOSITY 5 DESIRE TO BELONG TO A GROUP OR COMMUNITY OF SIMILAR PEOPLE 6 DIDN'T FEEL COMFORTABLE SAYING NO 7 OTHER REASON ( SPECIFY) _________________________

7. Is there anything that you especially like about participating in this study? ( ENTER VERBATIM)

____________________________

8. Is there anything you especially dislike about participating in this study? ( ENTER VERBATIM)

____________________________

9. Finally, do you have any recommendations as to what we could do differently in the overall study or in these interviews? ( ENTER VERBATIM) Female 18 Month ( instrument # 28)

34 ____________________________

{ END OF ACCEPTABILITY MODULE}


[Federal Register: February 20, 2008 (Volume 73, Number 34)]
[Proposed Rules]
[Page 9259-9260]
[DOCID:fr20fe08-30]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2007-0633; A-1-FRL-8517-5]

Approval and Promulgation of Air Quality Implementation Plans;
Maine; Conformity of General Federal Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The EPA is proposing to approve a State Implementation Plan
(SIP) revision submitted by the State of Maine for the purpose of
making the SIP consistent with recent additions to the Federal general
conformity regulation. This revision incorporates by reference new
definitions and establishes de minimis emission levels for fine
particular matter (PM2.5) into Maine's existing general
conformity criteria and procedures previously approved into the Maine
SIP.

DATES: Written comments must be received on or before March 21, 2008.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R01-
OAR-2007-0633 by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R01-OAR-2007-0633'', Anne Arnold, U.S. Environmental
Protection Agency, EPA New England Regional Office, One Congress
Street, Suite 1100 (mail code CAQ), Boston, MA 02114-2023.
    5. Hand Delivery or Courier. Deliver your comments to: Anne Arnold,
Manager, Air Quality Planning Unit, Office of Ecosystem Protection,
U.S. Environmental Protection Agency, EPA New England Regional Office,
One Congress Street, 11th floor, (CAQ), Boston, MA 02114-2023. Such
deliveries are only accepted during the Regional Office's normal hours
of operation. The Regional Office's official hours of business are
Monday through Friday, 8:30 to 4:30, excluding legal holidays.

    Please see the direct final rule which is located in the Rules
Section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: Donald O. Cooke, Air Quality Unit,
U.S. Environmental Protection Agency, EPA New England Regional Office,
One Congress Street, Suite 1100 (CAQ), Boston, MA 02114-2023, telephone
number<PHONE_NUMBER>, fax number<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: In the Final Rules Section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this rule, no
further activity is contemplated. If EPA receives adverse comments, the
direct final rule will be withdrawn and all public comments received
will be addressed in a subsequent final rule based on this proposed
rule. EPA will not institute a second comment period. Any parties
interested in commenting on this action should do so at this time.
Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment.
    For additional information, see the direct final rule which is
located in the Rules Section of this Federal Register.

    Dated: January 9, 2008.
Robert W. Varney,
Regional Administrator, EPA New England.
[FR Doc. E8-2883 Filed 2-19-08; 8:45 am]

BILLING CODE 6560-50-P