[Federal Register: July 30, 2009 (Volume 74, Number 145)]
[Notices]
[Page 38033-38034]
[DOCID:fr30jy09-65]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0324]

International Conference on Harmonisation; Draft Guidance on E16
Genomic Biomarkers Related to Drug Response: Context, Structure, and
Format of Qualification Submissions; 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availability of a draft guidance entitled ``E16 Genomic Biomarkers
Related to Drug Response: Context, Structure, and Format of
Qualification Submissions.'' The draft guidance was prepared under the
auspices of the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The draft guidance describes recommendations regarding context,
structure, and format of regulatory submissions for qualification of
genomic biomarkers. The draft guidance is intended to foster
consistency of applications across regions and facilitate joint
discussions with and among regulatory authorities.

DATES:  Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by September 28, 2009.

ADDRESSES:  Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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, Outreach and Development (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
draft guidance to the Division of Dockets Management (HFA-305), Food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 draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Federico Goodsaid, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2148, Silver Spring, MD 20903-0002, 301-
796-1535; or Jennifer Catalano, Center for Biologics Evaluation and
Research (HFM-735), Food and Drug Administration, 1401 Rockville Pike,
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

    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 June 2009, the ICH Steering Committee agreed that a draft
guidance entitled ``E16 Genomic Biomarkers Related to Drug Response:
Context, Structure, and Format of Qualification Submissions'' should be
made available for public comment. The draft guidance is the product of
the E16 Expert Working Group of the ICH. Comments about this draft will
be considered by FDA and the E16 Expert Working Group.
    The use of biomarkers in drug discovery, development, and
postapproval has the potential to facilitate development of safer and
more effective medicines, to guide dose selection, and to enhance the
benefit-risk profile of approved medicines. This draft guidance
describes recommendations regarding context, structure, and format of
regulatory submissions for qualification of genomic biomarkers. To
support the evaluation of genomic biomarkers, the draft guidance
describes and defines a submission standard applicable across regions.
The recommendations are based on previous experiences in the various
regions with submissions containing genomic biomarker data. Such
submissions have been either stand-alone biomarker qualification
applications or a component of medicinal product-related regulatory
process. Where appropriate, the proposed document format is expected to
facilitate incorporation of genomic biomarker data into specific
product-related applications.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent 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 on the draft guidance.
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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.regulations.gov, http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: July 23, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-18227 Filed 7-29-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: December 19, 2006 (Volume 71, Number 243)]
[Notices]
[Page 76004-76005]
[DOCID:fr19de06-93]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon written request, copies available from: Securities and Exchange
Commission Office of Filings and Information Services, Washington, DC
20549.

Extension: Rule 30e-2; SEC File No. 270-437; OMB Control No. 3235-
0494.

    Notice is hereby given that, under the Paperwork Reduction Act of
1995 (44 U.S.C. 350l-3520), the Securities and Exchange Commission (the
``Commission'') has submitted to the Office of Management and Budget
(``OMB'') a request for extension of the previously approved collection
of information discussed below.
    Section 30(e) of the Investment Company Act of 1940 (15 U.S.C. 80a-
29(e)) (the ``Investment Company Act'' or ``Act'') and Rule 30e-2 \1\
thereunder (17 CFR 270.30e-2) require registered unit investment trusts
(``UITs'') that invest substantially all of their assets in securities
of a management investment company \2\ (``fund'') to send to
shareholders at least semi-annually a report containing certain
financial statements and other information. Specifically, Rule 30e-2
requires that the report contain the financial statements and other
information that Rule 30e-1 under the Act (17 CFR 270.30e-1) requires
to be included in the report of the underlying fund for the same fiscal
period. Rule 30e-1 requires that the underlying fund's report contain,
among other things, the financial statements and other information that
is required to be included in such report by the fund's registration
form.
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    \1\ Rule 30e-2 was originally adopted as Rule 30d-2, but was
redesignated as Rule 30e-2 effective February 15, 2001. See Role of
Independent Directors of Investment Companies, Investment Company
Act Release No. 24816 (Jan. 2, 2001) (66 FR 3734 (Jan. 16, 2001)).
    \2\ Management investment companies are defined in Section 4(3)
of the Investment Company Act as any investment company other than a
face-amount certificate company or a unit investment trust, as those
terms are defined in Sections 4(1) and 4(2) of the Investment
Company Act. See 15 U.S.C. 80a-4.
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    The purpose of this requirement is to apprise current shareholders
of the operational and financial condition of the UIT. Absent the
requirement to disclose all material information in reports, investors
would be unable to obtain accurate information upon which to base
investment decisions and consumer confidence in the securities industry
might be adversely affected. Requiring the submission of these reports
to the Commission permits us to verify compliance with securities law
requirements. In addition, Rule 30e-2 permits, under certain
conditions, delivery of a single shareholder report to investors who
share an address (``householding''). Specifically, Rule 30e-2 permits
householding of annual and semi-annual reports by UITs to satisfy the
delivery requirements of Rule 30e-2 if, in addition to the other
conditions set forth in the rule, the UIT

has obtained from each applicable investor written or implied consent
to the householding of shareholder reports at such address. The rule
requires UITs that wish to household shareholder reports with implied
consent to send a notice to each applicable investor stating that the
investors in the household will receive one report in the future unless
the investors provide contrary instructions. In addition, at least once
a year, UITs relying on the rule for householding must explain to
investors who have provided written or implied consent how they can
revoke their consent. Preparing and sending the initial notice and the
annual explanation of the right to revoke consent are collections of
information under the Paperwork Reduction Act. The purpose of the
notice and annual explanation requirements associated with the
householding provisions of the rule is to ensure that investors who
wish to receive individual copies of shareholder reports are able to do
so.
    The Commission estimates that as of April 2006, approximately 737
UITs were subject to the provisions of Rule 30e-2. The Commission
further estimates that the annual burden associated with Rule 30e-2 is
121 hours for each UIT, including an estimated 20 hours associated with
the notice requirement for householding and an estimated 1 hour
associated with the explanation of the right to revoke consent to
householding, for a total of 89,177 burden hours.
    In addition to the burden hours, the Commission estimates that the
cost of contracting for outside services associated with complying with
Rule 30e-2 is $24,640 per respondent (80 hours times $308 per hour for
independent auditor services), for a total of $18,159,680 ($24,640 per
respondent times 737 respondents).
    These estimates are made solely for the purposes of the Paperwork
Reduction Act, and are not derived from a comprehensive or even a
representative survey or study of the costs of Commission rules and
forms.
    The collection of information under Rule 30e-2 is mandatory. The
information provided under Rule 30e-2 is not kept confidential. An
agency may not conduct or sponsor, and a person is not required to
respond to a collection of information unless it displays a currently
valid control number.
    Please direct general comments regarding the above information to
the following persons: (i) Desk Officer for the Securities and Exchange
Commission, Office of Management and Budget, Room 10102, New Executive
Office Building, Washington, DC 20503 or e-mail to:
<EMAIL_ADDRESS>and (ii) R. Corey Booth, Director/Chief

Information Officer, Securities and Exchange Commission, C/O Shirley
Martinson, 6432 General Green Way, Alexandria, VA, 22312; or send an e-
mail to<EMAIL_ADDRESS>Comments must be submitted to OMB within
30 days of this notice.

    Dated: December 11, 2006.
Nancy M. Morris,
Secretary.
 [FR Doc. E6-21588 Filed 12-18-06; 8:45 am]

BILLING CODE 8011-01-P