[Federal Register Volume 78, Number 37 (Monday, February 25, 2013)]
[Notices]
[Pages 12764-12765]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04254]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Draft Office of Health Assessment and Translation Approach for 
Systematic Review and Evidence Integration for Literature-Based Health 
Assessments--February 2013; Request for Comments; Notice of a Meeting

SUMMARY: The National Toxicology Program (NTP) requests public comments 
on the Draft Office of Health Assessment and Translation (OHAT) 
Approach for Systematic Review and Evidence Integration for Literature-
Based Health Assessments--February 2013 (available at http://ntp.niehs.nih.gov/go/38138). The NTP also plans to release two 
protocols to illustrate the application of this framework. These 
documents were prepared by the OHAT, Division of NTP, National 
Institute of Environmental Health Sciences (NIEHS). The NTP will hold a 
public web-based, informational meeting during the public-comment 
period to provide an overview of the framework, describe the contents 
in the case-study protocols, and respond to questions from the public 
on any of the documents.

DATES: Public Comment Submissions: Deadline is June 11, 2013.
    Document Availability: Draft OHAT Approach--February 2013 will be 
available by February 26, 2013, and case-study protocols should be 
available on April 2, 2013, at http://ntp.niehs.nih.gov/go/38673.
    Registration for public, web-based, informational meeting: Deadline 
is April 16, 2013.
    Meeting: April 23, 2013, 12:00-4:00 p.m. Eastern Daylight Time 
(EDT). The meeting may end earlier depending on the number of 
registered participants and will be cancelled if there are no 
registered participants by close of business on April 16, 2013. 
Registrants will receive information by email to access the web-based 
meeting on or before April 19, 2013.

ADDRESSES: Agency Web site: The Draft OHAT Approach--February 2013, 
protocols, registration for web-based meeting, and public comments are 
at http://ntp.niehs.nih.gov/go/38673.
    Public Comment Submissions: Email: andrew.rooney@nih.gov or submit 
on-line at http://ntp.niehs.nih.gov/go/38673.
    TTY users should contact the Federal TTY Relay Service at (800) 
877-8330. Requests must be made at least 5 business days in advance of 
the web-based meeting.

FOR FURTHER INFORMATION CONTACT: Dr. Andrew Rooney, Deputy Director, 
OHAT, Division of NTP, NIEHS, P.O. Box 12233, K2-04, Research Triangle 
Park, NC 27709. Phone: 919-541-2999, Fax: 301-480-3299, Email: 
Andrew.Rooney@nih.gov. Hand Deliver/Courier address: 530 Davis Drive, 
Room K2154, Morrisville, NC 27560.

SUPPLEMENTARY INFORMATION: 

Background

    The OHAT, Division of NTP, NIEHS, has led an effort for the NTP to 
develop an approach for carrying out literature-based health 
assessments that incorporates systematic review methodology. Systematic 
review and plans for developing the approach were introduced at the NTP 
Board of Scientific Counselors (BSC) meeting on June 21--22, 2012. A 
BSC working group reviewed an earlier draft of the approach (then 
called the draft NTP Approach) at a meeting on August 28--29, 2012, and 
provided a draft report with recommendations to the BSC at its meeting 
on December 11, 2012; the report was unanimously accepted by the BSC. 
Information, presentations, and minutes (when available) from the June 
and December meetings are available at http://ntp.niehs.nih.gov/go/9741.

[[Page 12765]]

    The NTP prepared the ``Draft OHAT Approach for Systematic Review 
and Evidence Integration for Literature-based Health Assessments--
February 2013,'' (Draft OHAT Approach--February 2013) taking into 
consideration input from the BSC working group, the BSC, and the public 
(available at http://ntp.niehs.nih.gov/go/38673). The approach includes 
seven steps that provide a framework for incorporating systematic 
review and evidence integration into NTP literature-based health 
assessments. To assist with determining if additional refinement or 
revision to the Draft OHAT Approach--February 2013 might be needed, 
OHAT plans to apply it to two case-study evaluations. One case study 
will evaluate the association of bisphenol A (BPA) exposure with 
obesity and the other will examine the association of perflurooctanoic 
acid (PFOA) or perfluorooctane sulfonate (PFOS) exposure with 
immunotoxicity. Prior to initiating these evaluations, OHAT is 
developing protocols that include specific elements for how the seven 
steps in the Draft OHAT Approach--February 2013 would be carried out. 
The protocols on BPA exposure and obesity and PFOA or PFOS exposure and 
immunotoxicity should be available on April 2, 2013, at http://ntp.niehs.nih.gov/go/38673. Persons interested in the Draft OHAT 
Approach--February 2013 and the protocols are encouraged to access this 
Web site to stay abreast of the most current information.
    The NTP will carefully consider the public comments on the Draft 
OHAT Approach--February 2013 and consider what changes, if any, might 
be needed. The NTP plans to present the Draft OHAT Approach--February 
2013 to the NTP BSC at the meeting on June 25-26, 2013 and discuss 
plans to update the document based on comments. Details about this 
meeting will be published in the Federal Register and posted on the NTP 
Web site (http://ntp.niehs.nih.gov/go/165).

Request for Comments

    The NTP invites public comments on the Draft OHAT Approach--
February 2013. Two protocols are being released to illustrate 
application of this framework: BPA exposure and obesity and PFOA or 
PFOS exposure and immunotoxicity. The deadline for submission of public 
comments is June 11, 2013. Comments will be posted on the NTP Web site 
http://ntp.niehs.nih.gov/go/38668 and persons submitting them will be 
identified by their name and affiliation and/or sponsoring 
organization, if applicable. Public comments can be submitted on-line 
or by email (see ADDRESSES, Public Comment Submissions). Persons 
submitting written comments should include their name, affiliation (if 
applicable), phone, email, and sponsoring organization (if any) with 
the document.

Web-based Informational Meeting

    The NTP will hold a public, web-based, informational meeting on 
April 23, 2013, 12:00-4:00 p.m. EDT to provide an overview of the Draft 
OHAT Approach--February 2013, describe the contents in the two case-
study protocols, and respond to questions from the public on any of the 
documents. The meeting will be interactive and opportunities will be 
provided for members of the public to ask NTP staff specific questions 
that may assist in their review or understanding of the Draft OHAT 
Approach--February 2013. The deadline for registration for the webinar 
is April 16 at http://ntp.niehs.nih.gov/go/38673, and the event will be 
cancelled if there are no registered participants by close of business 
that day. Registrants will receive information by email to access the 
web-based meeting on or before April 19, 2013.

Background Information on OHAT

    OHAT was established to serve as an environmental health resource 
to the public and regulatory and health agencies (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3094430). This office conducts 
evaluations to assess the evidence that environmental chemicals, 
physical substances, or mixtures (collectively referred to as 
``substances'') cause adverse health effects and provides opinions on 
whether these substances may be of concern given what is known about 
current human exposure levels. OHAT also organizes workshops or state-
of-the-science evaluations to address issues of importance in 
environmental health sciences. OHAT assessments are published as NTP 
Monographs. Information about OHAT is found at http://ntp.niehs.nih.gov/go/ohat.

    Dated: February 19, 2013.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2013-04254 Filed 2-22-13; 8:45 am]
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