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Federal Register / Vol. 72, No.

222 / Monday, November 19, 2007 / Notices 65047

SUPPLEMENTARY INFORMATION: committee meetings. It does not create Need and use of information collection:
or confer any rights for or on any person The NICHD seeks to obtain OMB’s
I. Background
and does not operate to bind FDA or the generic approval to conduct pilot and
FDA is announcing the availability of public. An alternative approach may be formative research to be used in the
a draft guidance for FDA advisory used if such approach satisfies the development of instruments, materials,
committee members and FDA staff requirements of the applicable statutes and procedures for the National
entitled, ‘‘Voting Procedures for and regulations. Children’s Study (NCS). The NCS is a
Advisory Committee Meetings,’’ dated long-term cohort study of environmental
November 2007. II. Comments
influences on child health and
FDA’s advisory committees provide Interested persons may submit to the development authorized under the
independent, expert advice to the Division of Dockets Management (see Children’s Health Act of 2000. The Act
agency on a range of complex scientific, ADDRESSES) written or electronic specifies a broad definition of
technical, and policy issues, including comments regarding this document. environment, including biologic,
questions related to the development Submit a single copy of electronic chemical, physical, and psycho-social
and evaluation of products regulated by comments or two paper copies of any factors and authorizes the NICHD to
FDA. Advisory committees are a mailed comments, except that plan, develop, and implement a
valuable resource to FDA, and they individuals may submit one paper copy.
make an important contribution to the prospective cohort study, from birth to
Comments are to be identified with the adulthood, to evaluate the effects of
agency’s decision-making processes. docket number found in brackets in the
Although advisory committees provide those exposures on child health and
heading of this document. Received human development. Further details
recommendations to FDA, FDA makes comments may be seen in the Division
the final decisions. pertaining to the NCS background and
of Dockets Management between 9 a.m. planning, including the NCS Research
Advisory committees typically and 4 p.m., Monday through Friday.
communicate advice or Plan, can be found at: http://
Please note that in January 2008, the
recommendations to the agency in two nationalchildrensstudy.gov. The
FDA Web site is expected to transition
ways. First, committee members proposed data collection program will
to the Federal Dockets Management
routinely share their individual include community outreach materials,
System (FDMS). FDMS is a
thoughts and recommendations during medical provider and participant
Government-wide, electronic docket
the discussion of a particular matter at materials, questionnaires and measures,
management system. After the transition
an advisory committee meeting. Second, use of technology such as Interactive
date, electronic submissions will be
advisory committees often vote on a Voice Recognition (IVR), and other
accepted by FDA through the FDMS
question or series of questions posed to aspects related to data collection.
only. When the exact date of the
the committee during a committee Activities will include small focused
transition to FDMS is known, FDA will
meeting. studies to test data collection items and
publish a Federal Register notice
Votes can be an effective means of methods on a specific or targeted
announcing that date.
communicating with FDA because they population, validation of questionnaires
provide feedback on discrete questions. Dated: November 14, 2007. for targeted populations, focus groups
These questions are generally scientific Randall W. Lutter, within the NCS communities to test
in nature and can involve a range of Deputy Commissioner for Policy. forms and procedures, cognitive
subjects, including evaluation of post- [FR Doc. 07–5751 Filed 11–15–07; 9:06 am] interviews to test data items, and the
market safety data or pre-market BILLING CODE 4160–01–S use of materials on targeted populations
assessment of a product’s risk/benefit such as medical providers and
profile. Since all members vote on the hospitals, and materials translated into
same question, the results help FDA DEPARTMENT OF HEALTH AND other languages. These activities will be
gauge a committee’s collective view on HUMAN SERVICES conducted over the life of the study to
complex, multi-faceted issues. This develop procedures and materials for
view helps inform the agency’s own National Institutes of Health each stage of data collection. The results
deliberations on scientific and of these pilot tests will be used to
National Institute of Child Health and maximize the efficiency of study
regulatory matters. Human Development; Proposed
This draft guidance recommends procedures, materials, and methods for
Collection; Comment Request; community outreach, engagement of the
adopting uniform voting procedures to
Formative Research and Pilot Studies medical community, for recruiting and
help maximize the integrity and
for the National Children’s Study retaining study subjects prospectively
meaning of voting results. In developing
these recommendations, FDA is mindful SUMMARY: In compliance with the across study visits and to ensure that
of the legal requirements of the Federal requirement of section 3506(c)(2)(A) of data collection methodologies are
Advisory Committee Act, other relevant the Paperwork Reduction Act of 1995, efficient and valid for all potential
statutes (e.g., the Federal Food, Drug, for opportunity for public comment on participants. Without this information,
and Cosmetic Act), regulations (e.g., 21 proposed data collection projects, the NCS will be hampered in its efforts to
CFR Part 14) , guidance, and policies, National Institute of Child Health and effectively publicize the NCS, gain
and the goals of FDA’s of advisory Human Development (NICHD), the public and professional support, and
committee program. National Institutes of Health (NIH) will effectively recruit and retain
This draft guidance is being issued publish periodic summaries of proposed respondents and collect data over the
consistent with FDA’s good guidance projects to be submitted to the Office of life of the Study. Affected entities:
practices regulation (21 CFR 10.115). Management and Budget (OMB) for Individuals. Types of respondents:
rwilkins on PROD1PC63 with NOTICES

The draft guidance represents the review and approval. People potentially affected by this
agency’s current thinking on Proposed Collection: Title: Formative action are pregnant women or women of
recommended uniform procedures that Research and Pilot Studies for the childbearing age, their husbands or
can be used for the voting process when National Children’s Study. Type of partners, health care professionals, and
votes are taken during advisory Information Collection Request: NEW. community leaders. The annual

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65048 Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / Notices

reporting burden is as follows: Respondent: 1. Average Burden Hours $114,250 (based on rates listed in the
Estimated Number of Respondents: Per Response: Varies with study type. burden table). There are no Capital
3,150. Frequency of Response: On Estimated Total Annual Burden Hours Costs to report. There are no Operating
occasion (see Burden table). The Requested: 5,825. The estimated or Maintenance Costs to report.
Estimated Number of Responses per annualized cost to respondents is

Estimated
Estimated Average Estimated total
Type of respondents number of
number of burden hours annual burden
(estimated hourly rate) responses per
respondents per response hours
respondent

Small focused studies ($10) ............................................................................ 1,250 1 1.5 1,875


Focus groups with potential participants ($10) ................................................ 350 1 3.0 1,050
Focus groups with health care professionals ($50) ........................................ 350 1 3.0 1,050
Focus groups with community leaders ($10) .................................................. 350 1 3.0 1,050
Medical provider feedback on materials through informal in-person contacts
($50) ............................................................................................................. 700 1 0.5 350
Cognitive interviews ($10) ............................................................................... 150 1 3.0 450

Total .......................................................................................................... 3,150 ........................ ........................ 5,825

Requests for Comments: Written DEPARTMENT OF HEALTH AND its research portfolio. Focusing
comments and/or suggestions from the HUMAN SERVICES specifically on one portion of the
public and affected agencies are invited research portfolio—asthma research—
on one or more of the following points: National Institutes of Health DERT proposes to supplement extant
(1) Whether the proposed collection of data sources with a primary data
information is necessary for the proper National Institute of Environmental collection activity. The purpose of the
performance of the function of the Health Sciences; Division of
proposed primary data collection is to
agency, including whether the Extramural Research and Training;
obtain information from grantees
information will have practical utility; Submission for OMB Review;
regarding the impact of their funded
(2) The accuracy of the agency’s Comment Request; Program
Assessment and Evaluations for asthma research in the short-,
estimate of the burden of the proposed intermediate-, and long-term. This will
collection of information, including the NIEHS—Asthma Research
be done through a survey of grantees
validity of the methodology and Summary: Under the provision of that includes questions about the impact
assumptions used; (3) Ways to enhance Section 3507(a)(1)(D) of the Paperwork of funding on career development, the
the quality, utility, and clarity of the Reduction Act of 1995, the National field of asthma research, public
information to be collected; and (4) Institute of Environmental Health attitudes, commercial product
Ways to minimize the burden of the Sciences (NIEHS), the National development, clinical practice, business
collection of information on those who Institutes of Health (NIH) has submitted and industry practices, and long-term
are to respond, including the use of to the Office of Management and Budget human and environmental health.
appropriate automated, electronic, (OMB) a request for review and Frequency of Response: One time.
mechanical, or other technological approval of the information collection Affected Public: Individuals. Type of
collection techniques or other forms of listed below. This proposed information Respondents: Individuals receiving
information technology. collection was previously published in asthma funding. A 15-minute, close-
the Federal Register on May 9, 2007,
FOR FURTHER INFORMATION CONTACT: To ended, multi-mode (web and paper)
page 26399 and allowed 60 days for
request more information on the survey will be administered to the
public comment. No public comments
proposed project or to obtain a copy of universe of NIEHS-funded asthma
were received. The purpose of this
the data collection plans and researchers (N=179) and comparison
notice is to allow an additional 30 days
instruments, contact Ruth A. Brenner, for public comment. The National agency asthma researchers (N=1371).
MD, MPH, National Institute of Child Institutes of Health may not conduct or Comparison agencies include other NIH
Health and Human Development, sponsor, and the respondent is not institutes (NICHD, NIAID, NIA, NHLBI),
Building 6100, 5C01, 6100 Executive required to respond to, an information the CDC, AHRQ, and the EPA. The
Blvd, Bethesda, Maryland 20892, or call collection that has been extended, survey development process included
non-toll free number (301) 594–9147, or revised, or implemented on or after formative interviews with a small
e-mail your request, including your October 1, 1995, unless it displays a sample of NIEHS asthma researchers.
address to ncsinfo@mail.nih.gov. currently valid OMB control number. The annual reporting burden is as
Comments Due Date: Comments Proposed Collection: Title: Program follows: Estimated Number of
regarding this information collection are Assessment and Evaluations for Respondents: 1550; Estimated Number
best assured of having their full effect if NIEHS—Asthma Research. Type of of Responses per Respondent: 1;
received within 60 days of the date of Information Collection Request: NEW. Average Burden Hours per Response: 15
this publication. New and Use of Information Collection: minutes; and Estimated Total Annual
National Institute of Environmental Burden Hours Requested: 387.5. The
Paul Johnson, Health Sciences, Division of Extramural annualized cost to respondents is
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NICHD Project Clearance Liaison, National Research and Training (DERT). DERT, estimated at $13,039.38. There are no
Institutes of Health. with contract support from Battelle Capital Costs to report. There are no
[FR Doc. E7–22592 Filed 11–16–07; 8:45 am] Centers for Public Health Research and Operating or Maintenance Costs to
BILLING CODE 4140–01–P Evaluation, is examining the impact of report.

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