[Federal Register: April 8, 2008 (Volume 73, Number 68)]
[Notices]
[Page 19074-19076]
[DOCID:fr08ap08-59]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0199] (formerly Docket No. 2006D-0526)

International Conference on Harmonisation; Guidance on E15
Pharmacogenomics Definitions and Sample Coding; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``E15 Definitions for Genomic
Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample
Coding Categories.'' The guidance was prepared

under the auspices of the International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for Human
Use (ICH). The guidance contains definitions of key terms in the
discipline of pharmacogenomics and pharmacogenetics, namely genomic
biomarkers, pharmacogenomics, pharmacogenetics, and genomic data and
sample coding categories. In the effort to develop harmonized
approaches to drug regulation, it is important to ensure that
consistent definitions of terminology are being applied across all
constituents of the ICH. The guidance is intended to facilitate the
integration of the discipline of pharmacogenomics and pharmacogenetics
into global drug development and approval processes.

DATES:  Submit written or electronic comments on agency guidance at any
time.

ADDRESSES:  Submit written requests for single copies of the guidance
to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; or
the Office of Communication, Training and Manufacturers Assistance
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and
Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The
guidance may also be obtained by mail by calling CBER at 1-800-835-4709
or<PHONE_NUMBER>. Send two self-addressed adhesive labels to assist the
office in processing your requests. Submit written comments on the
guidance to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.Submit
electronic comments to http://www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.
    Regarding the guidance: Felix Frueh, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
21, rm. 4512,Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
    Raj K. Puri, Center for Biologics Evaluation and Research (HFM-
735), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448,<PHONE_NUMBER>.
    Regarding the ICH: Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled ``E15
Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics,
Genomic Data and Sample Coding Categories.'' In recent years, many
important initiatives have been undertaken by regulatory authorities
and industry associations to promote international harmonization of
regulatory requirements. FDA has participated in many meetings designed
to enhance harmonization and is committed to seeking scientifically
based harmonized technical procedures for pharmaceutical development.
One of the goals of harmonization is to identify and then reduce
differences in technical requirements for drug development among
regulatory agencies.
    ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA; and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
    In the Federal Register of January 8, 2007 (72 FR 793), FDA
published a notice announcing the availability of a draft guidance
entitled ``E15 Terminology in Pharmacogenomics.'' The notice gave
interested persons an opportunity to submit comments by April 9, 2007.
    After consideration of the comments received and revisions to the
guidance, a final version of the draft guidance was submitted to the
ICH Steering Committee and endorsed by the three participating
regulatory agencies in October 25, 2006.
    The guidance represents an international effort to harmonize
pharmacogenomics definitions and sample coding. Inconsistent
definitions make it difficult to achieve agreement on parameters for
implementation of pharmacogenomics in global pharmaceutical
development, and might lead to inconsistent assessments by regulators.
The guidance provides definitions of key terms in the discipline of
pharmacogenomics and pharmacogenetics, namely genomic biomarkers,
pharmacogenomics, pharmacogenetics, and genomic data and sample coding
categories. The guidance is intended to facilitate the integration of
the discipline of pharmacogenomics and pharmacogenetics into global
drug development and approval processes. Timely harmonization of
terminology and definitions will create a common foundation for future
guidance on pharmacogenomics.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on this topic. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic

comments or submissions will be accepted by FDA through FDMS only.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/ohrms/dockets/default.htm, http://www.fda.gov/cder/
guidance/index.htm, or http://www.fda.gov/cber/publications.htm.

    Dated: March 28, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-7237 Filed 4-7-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 80, Number 181 (Friday, September 18, 2015)]
[Proposed Rules]
[Page 56422]
[FR Doc No: 2015-23384]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[EPA-R07-OAR-2015-0514; FRL-9933-96-Region 7]

Approval and Promulgation of Air Quality Implementation Plans for
Designated Facilities and Pollutants; Missouri; Sewage Sludge
Incinerators

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the state plan for designated facilities and
pollutants developed under sections 111(d) and 129 of the Clean Air Act
for the State of Missouri. This proposed action will amend the state
plan to include a new plan and associated rule implementing the
emissions guidelines for Commercial and Industrial Solid Waste
Incineration (CISWI) Units.

DATES: Comments on this proposed action must be received in writing by
October 19, 2015.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2015-0514, by mail to Paula Higbee, Environmental Protection
Agency, Air Planning and Development Branch, 11201 Renner Boulevard,
Lenexa, Kansas 66219. Comments may also be submitted electronically or
through hand delivery/courier by following the detailed instructions in
the ADDRESSES section of the direct final rule located in the rules
section of this Federal Register.

FOR FURTHER INFORMATION CONTACT: Paula Higbee, Environmental Protection
Agency, Air Planning and Development Branch, 11201 Renner Boulevard,
Lenexa, Kansas 66219 at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the final rules section of this Federal
Register, EPA is approving the state's SIP revision as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial revision amendment and anticipates no relevant adverse
comments to this action. A detailed rationale for the approval is set
forth in the direct final rule. If no relevant adverse comments are
received in response to this action, no further activity is
contemplated in relation to this action. If EPA receives relevant
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 action. EPA will not institute a second comment
period on this action. Any parties interested in commenting on this
action should do so at this time. Please note that if EPA receives
adverse comment on part of this rule and if that part can be severed
from the remainder of the rule, EPA may adopt as final those parts 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.

List of Subjects in 40 CFR Part 62

    Environmental protection, Administrative practice and procedure,
Air pollution control, Commercial and industrial solid waste
incinerators, Intergovernmental relations, Reporting and recordkeeping
requirements.

    Dated: September 3, 2015.
Becky Weber,
Acting Regional Administrator, Region 7.
[FR Doc. 2015-23384 Filed 9-17-15; 8:45 am]
BILLING CODE 6560-50-P