Federal Register: December 16, 2003 (Volume 68, Number 241)
DOCID: FR Doc 03-31023
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
NOTICE: NOTICES
SUBJECT CATEGORY:
Agency Information Collection Activities: Proposed Collection; Comment Request
DATES: Comments on this notice must be received by February 17, 2004.
DOCUMENT 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 PracticeBased Research Networks (PBRNs).'' In accordance with the Paperwork Reduction Act of 1995, Public Law 100413 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.
SUMMARY:
Agency information collection activities; proposals, submissions, and approvals,
DOCUMENT BODY:
N
otice.
SUPPLEMENTAL 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 ``Recourse Center for Primary Care PracticeBased Research Networks (PBRNs)'' (issued under Contract 290020008). 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 wellestablished 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
[[Page 70017]]
consist mainly of nonacademic, communitybased primary care practices
with wellestablished 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 NCS 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 involve use of inperson interviews, developmental assessments of children, selfadministered parent/ guardian questionnaires, and physical exams including the collection of urine. The pilot study will evaluate the feasibility of having PBRNs participate in the NCS using several indicators:
The ability of practices to use selfadministered 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 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 visit another practice participating in the pilot study in order to test the ability of practices to collect and manage data on nonmember 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
selfadministered questionnaires, physical examination, and collection
of a urine sample. The practice will contact potential participants
through a mailing and a phone call. Nonrespondents will not be contacted again.
Estimated Annual Respondent Burden
Estimated time Estimated
Data collection Number of per respondent total burden Average hourly Labor rates
respondents in hours hours wage rate
Pregnant woman: Data collected 403 2.5 1007.5 17.18* $17,308.85 at their current practice......
Pregnant woman: Data collected 101 3 303 17.18* 5,205.54 at a practice other than usual
source of care.................
Parent of a 1 year old or 5 year 403 4 1,612 17.18* 27,694.16 old: Data collected at their
current practice...............
Parent of a 1 year old or 5 year 101 4.5 454.5 17.18* 7,808.31 old: Data collected at a
practice other than usual
source of care.................
1 year old or 5 year old: Data 403 4 1,612 0 0.00 collected at their usual
practice.......................
1 year old or 5 year old: Data 101 4.5 454.5 0 0.00 collected at their usual
practice.......................
Total....................... 1512 3.6 5443.50 .............. $58,016.86 * 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.
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: December 10, 2003.
Carolyn M. Clancy,
Director.
[FR Doc. 0331023 Filed 121203; 10:46 am]
BILLING CODE 416090M
FOR FURTHER INFORMATION CONTACT
Cynthia D. McMichael, AHRQ, Reports Clearance Officer, (301) 4271651.