[Federal Register Volume 69, Number 37 (Wednesday, February 25, 2004)]
[Notices]
[Pages 8662-8663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-4098]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Agency for Healthcare Research and Quality, HHS.

ACTION: Notice.

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SUMMARY: This notice announces the intention of the Agency for 
Healthcare Research and Quality (AHRQ) to request that the Office of 
Management and Budget (OMB) allow the proposed information collection 
project: ``National Children's Study Pilot: Primary Care Practice-Based 
Research Networks (PBRNs).'' In accordance with the Paperwork Reduction 
Act of 1995, Public Law 104-13 (44 U.S.C. 3506 (c)(2)(A)), AHRQ invites 
the public to comment on this proposed information collection.
    This proposed information collection was previously published in 
the Federal Register on December 16, 2003 and allowed 60 Days for 
public comment. No public comments were received. The purpose of this 
notice is to allow an additional 30 Days for public comment.

DATES: Comments on this notice must be received by March 26, 2004.

ADDRESSES: Written comments should be submitted to: Allison Eydt, Human 
Resources and Housing Branch, Office of Information and Regulatory 
Affairs, OMB, New Executive Office Building, Room 10235, Washington, DC 
20503.

FOR FURTHER INFORMATION CONTACT: Cynthia D. McMichael, AHRQ, Reports 
Clearance Officer, (301) 427-1651.

SUPPLEMENTARY INFORMATION:

Proposed Project

    ``National Children's Study pilot project to determine feasibility 
of NCS data collection in Primary Care Practices.''
    The project is being conducted in response to a modification of an 
AHRQ RFP entitled ``Resource Center for Primary Care Practice-Based 
Research Networks (PBRNs)'' (issued under Contract 290-02-0008).
    In January 2003 AHRQ requested that the PBRN Resource Center assess 
the potential for PBRNs to participate in the National Children's Study 
(NCS).
    In 2000, Congress passed the Children's Health Act, authorizing an 
unprecedented study of the impact of the environment on children's 
health.
    The goal of the NCS is to identify sufficient numbers of women of 
childbearing age to enroll 100,000 pregnant women into the NCS early in 
gestation, and then to enroll and follow their children through 21 
years of age.
    A key design issue for the NCS is the manner in which participants 
will be recruited and enrolled into the study. Previous research states 
that a well-established relationship between the researcher and the 
subject, convenient study location and active community ties bolster 
recruitment success and the likelihood of a parent to enroll their 
child in longitudinal studies. PBRNs consist mainly of non-academic, 
community-based primary care practices with well-established 
relationships with their subject population. PBRNs therefore offer a 
potentially valuable resource for identifying, enrolling, and following 
women and children for the NCS.
    Recognizing this, AHRQ requested that the Resource Center 
participate in the design of a pilot study of PBRNs' ability to 
participate in the NCS. The proposed NC pilot study will test the 
ability of PBRNs to collect, process, and manage data similar to that 
which is expected to be collected and processed in the NCS.
    This pilot study will allow the Resource Center to determine the 
factors that enable or hinder the collection of such data at primary 
care practices, as well as make an overall determination of the 
feasibility of PBRN practices' participation in the NCS.
    The pilot study will collect data using several instruments and 
will involve multiple individuals at the clinic: (1) A trained 
interviewer will administer a questionnaire on medical and nutritional 
history; (2) the same trained interviewer will conduct a developmental 
assessment of each child; (3) a nurse or physician's assistant will 
collect vital signs and a urine specimen; (4) a physician will conduct 
a brief physical exam; and (5) study participants will complete self-
administered questionnaires about the experience of participating in 
the study. The pilot study will evaluate the feasibility of having 
PBRNs participate in the NCS using several indicators:
    The ability of practices to use self-administered questionnaires to 
collect and manage the medical and dietary history data of pregnant 
women and of children ages 1 and 5;
    The ability of practices to effectively collect and manage data 
from a physical examination of study subjects (including health status 
and urine collection);
    The ability of practices to facilitate a developmental assessment 
of children conducted at age one and age five;
    The amount of burden data collection places on practices;
    The characteristics of successful and unsuccessful practices in the 
study;
    The ease of data collection across different patient populations 
and data collection modes and;
    To make the necessary determinations, assessments and surveys will 
be conducted with PBRN practice patients as well as with a small number 
of patients who ordinarily receive care elsewhere, and PBRN staff will 
also be surveyed.

Methods of Collection

    The data will be collected from 36 practices per respondent 
category, meaning 36 practices will collect data on pregnant women, 36 
practices will collect data on children aged 1 and 5. It is expected 
that some practices will collect data on more than one respondent 
group. Each practice will recruit 14 patients per respondent group 
using convenience sampling procedures. A total of 504 pregnant

[[Page 8663]]

women and 504 children and their parents (half will be 1 year old and 
half will be 5 years old) will be involved in the data collection. 
Because a small proportion (20%) of patients will be asked to vising 
another practice participating in the pilot study in order to test the 
ability of practices to collect and manage data on non-member patients, 
the NCS will require some providers to collect data on some patients 
they do not normally care for.
    The method of data collection for the patient assessment includes 
self-administered questionnaires, physical examination, and collection 
of a urine sample.
    The practice will contact potential participants through a mailing 
and a phone call. Non-respondents will not be contacted again.

                                                           Estimated Annual Respondent Burden
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                                                                 Estimated time     Estimated
                Data collection                     Number of    per respondent   total burden           Average hourly wage rate           Labor rates
                                                   respondents      in hours          hours
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Pregnant woman: Data collected at their current             432             3.5           1,512  $17.18.................................       $25,976.0
 practice.                                                                                       (*see footnotes).......................               0
Pregnant woman: Data collected at a practice                108             4.5             486  17.18..................................        8,350.00
 other than usual source of care.                                                                (*see footnotes).......................
Parent of a 1 year old or 5 year old: Data                  432             3.5           1,512  17.18..................................        25,976.0
 collected at their current practice.                                                            (*see footnotes).......................               0
Parent of a 1 year old or 5 year old: Data                  108             4.5             486  17.18..................................        8,350.00
 collected at a practice other than usual                                                        (*see footnotes).......................
 source of care.
1 year old or 5 year old: Data collected at                 432             3.5           1,512  0......................................            0.00
 their usual practice.
1year old or 5 year old: Data collected at                  108             4.5             486  0......................................            0.00
 their usual practice.
    Total......................................            1620              24            5994  .......................................        68,652.0
                                                                                                                                                      0
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 Footnotes: *based on the average hourly wage across private and public sector jobs in the United States, National Compensation Survey, July 2002. U.S.
  Bureau of Labor Statistics.

Estimated Costs to the Federal Government

    The total cost to the government for activities directly related to 
this data collection is estimated to be $780,411 for the pilot study.

Request for Comments

    In accordance with the above cited legislation, comments on the 
AHRQ information collection are requested with regard to any of the 
following: (a) Whether the proposed collection of information is 
necessary for the proper performance of functions of AHRQ, including 
whether the information will have practical utility;
    (b) the accuracy of the AHRQ's estimate of burden (including hours 
and cost) of the proposed collection of information;
    (c) ways to enhance the quality, utility, and clarity of the 
information to be collected; and
    (d) ways to minimize the burden of the collection of information 
upon the respondents, including the use of automated collection 
techniques or other forms of information technology.
    Comments submitted in response to this notice will be summarized 
and included in the request for OMB approval of the proposed 
information collection. all comments will become a matter of public 
record.

    Dated: February 17, 2004.
Carolyn M. Clancy,
Director.
[FR Doc. 04-4098 Filed 2-24-04; 8:45 am]
BILLING CODE 4160-90-M