International Conference on Harmonisation; Draft Guidance on E15 Terminology in Pharmacogenomics; Availability, 793-794 [E7-5]
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Federal Register / Vol. 72, No. 4 / Monday, January 8, 2007 / Notices
toxicological data on the substance and
its impurities, and (6) information on
the environmental impact that would
result from the proposed use.
FDA uses this information to
determine whether the food-contact
article meets the threshold criteria.
Respondents to this information
collection are individual manufacturers
and suppliers of substances used in
food-contact articles (i.e., food
packaging and food processing
equipment) or of the articles themselves.
FDA estimates the burden of this
collection of information as follows:
contact article meets the threshold
criteria, certain information specified in
§ 170.39(c) must be submitted to FDA.
This information includes the following
components: (1) The chemical
composition of the substance for which
the request is made, (2) detailed
information on the conditions of use of
the substance, (3) a clear statement of
the basis for the request for exemption
from regulation as a food additive, (4)
data that will enable FDA to estimate
the daily dietary concentration resulting
from the proposed use of the substance,
(5) results of a literature search for
regulation or an effective notification.
The agency has established two
thresholds for the regulation of
substances used in food-contact articles.
The first exempts those substances used
in food-contact articles where the
resulting dietary concentration would
be at or below 0.5 part per billion (ppb).
The second exempts regulated direct
food additives for use in food-contact
articles where the resulting dietary
exposure is 1 percent or less of the
acceptable daily intake for these
substances.
In order to determine whether the
intended use of a substance in a food-
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of Respondents
170.39
jlentini on PROD1PC65 with NOTICES
1 There
Annual Frequency per
Response
15
Total Annual Responses
1
Hours per Response
15
48
Total Hours
720
are no capital costs or operating and maintenance costs associated with this collection of information.
In compiling these estimates, FDA
consulted its records of the number of
regulation exemption requests received
in the past 3 years. The annual hours
per response reporting estimate is based
on information received from
representatives of the food packaging
and processing industries and agency
records.
FDA estimates that approximately 15
requests per year will be submitted
under the threshold of regulation
exemption process of § 170.39. The
threshold of regulation process offers
one advantage over the premarket
notification process for food-contact
substances established by section 409(h)
of the act (OMB control number 0910–
0495) in that the use of a substance
exempted by the agency is not limited
to only the manufacturer or supplier
who submitted the request for an
exemption. Other manufacturers or
suppliers may use exempted substances
in food-contact articles as long as the
conditions of use (e.g., use levels,
temperature, type of food contacted,
etc.) are those for which the exemption
was issued. As a result, the overall
burden on both the agency and the
regulated industry would be
significantly less in that other
manufacturers and suppliers would not
have to prepare, and FDA would not
have to review, similar submissions for
identical components of food-contact
articles used under identical conditions.
Manufacturers and other interested
persons can easily access an up-to-date
list of exempted substances which is on
display at FDA’s Division of Dockets
Management and on the Internet at
https://www.cfsan.fda.gov. Having the
VerDate Aug<31>2005
17:57 Jan 05, 2007
Jkt 211001
list of exempted substances publicly
available decreases the likelihood that a
company would submit a food additive
petition or a notification for the same
type of food-contact application of a
substance for which the agency has
previously granted an exemption from
the food additive listing regulation
requirement.
Dated: December 29, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–6 Filed 1–5–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D–0526]
International Conference on
Harmonisation; Draft Guidance on E15
Terminology in Pharmacogenomics;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘E15 Terminology in
Pharmacogenomics.’’ 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 contains definitions
of key terms in the discipline of
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
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 draft guidance is intended
facilitate the integration of the
discipline of pharmacogenomics and
pharmacogenetics into global drug
development and approval processes.
DATES: Submit written or electronic
comments on the draft guidance by
April 9, 2007.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857; 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 draft
guidance may also be obtained by mail
by calling CBER at 1–800–835–4709 or
301–827–1800. Send two self-addressed
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 https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
E:\FR\FM\08JAN1.SGM
08JAN1
794
Federal Register / Vol. 72, No. 4 / Monday, January 8, 2007 / Notices
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
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,
301–796–1530; 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, 301–827–0471.
Regarding the ICH: Michelle Limoli,
Office of International Programs
(HFG–1), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–
4480.
SUPPLEMENTARY INFORMATION:
jlentini on PROD1PC65 with NOTICES
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).
VerDate Aug<31>2005
17:57 Jan 05, 2007
Jkt 211001
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 October 2006, the ICH Steering
Committee agreed that a draft guidance
entitled ‘‘E15 Terminology in
Pharmacogenomics’’ should be made
available for public comment. The draft
guidance is the product of the E15
Pharmacogenomics Expert Working
Group of the ICH. Comments about this
draft will be considered by FDA and the
E15 Pharmacogenomics Expert Working
Group.
The draft 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 draft 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. Timely
harmonisation of terminology and
definitions will create a common
foundation for future guidance on
pharmacogenomics.
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 https://
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
www.fda.gov/ohrms/dockets/
default.htm, https://www.fda.gov/cder/
guidance/index.htm, or https://
www.fda.gov/cber/publications.htm.
Dated: December 29, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–5 Filed 1–5–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
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Mental Health Services Administration
(SAMHSA)—(OMB No. 0930–0208)—
Revision.
The mission of the Substance Abuse
and Mental Health Services
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Data are collected from all SAMHSA
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quantify the effects and
E:\FR\FM\08JAN1.SGM
08JAN1
]]>Agencies
[Federal Register Volume 72, Number 4 (Monday, January 8, 2007)]
[Notices]
[Pages 793-794]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-5]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0526]
International Conference on Harmonisation; Draft Guidance on E15
Terminology in Pharmacogenomics; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``E15 Terminology in
Pharmacogenomics.'' 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 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
draft guidance is intended facilitate the integration of the discipline
of pharmacogenomics and pharmacogenetics into global drug development
and approval processes.
DATES: Submit written or electronic comments on the draft guidance by
April 9, 2007.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857; 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 draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or 301-827-1800. Send two self-
addressed 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 https://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY
INFORMATION section
[[Page 794]]
for electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
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, 301-796-1530; 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, 301-827-0471.
Regarding the ICH: Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4480.
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 October 2006, the ICH Steering Committee agreed that a draft
guidance entitled ``E15 Terminology in Pharmacogenomics'' should be
made available for public comment. The draft guidance is the product of
the E15 Pharmacogenomics Expert Working Group of the ICH. Comments
about this draft will be considered by FDA and the E15 Pharmacogenomics
Expert Working Group.
The draft 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 draft 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. Timely harmonisation of terminology and definitions will
create a common foundation for future guidance on pharmacogenomics.
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
https://www.fda.gov/ohrms/dockets/default.htm, https://www.fda.gov/cder/
guidance/index.htm, or https://www.fda.gov/cber/publications.htm.
Dated: December 29, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-5 Filed 1-5-07; 8:45 am]
BILLING CODE 4160-01-S
