Companion to Guidance for Industry on Pharmacogenomic Data; Availability, 49722-49723 [E7-17103]
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Federal Register / Vol. 72, No. 167 / Wednesday, August 29, 2007 / Notices
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Sandra L. Kusumoto,
Director, Bureau of Certification and
Licensing.
[FR Doc. E7–17139 Filed 8–28–07; 8:45 am]
Centers for Disease Control and
Prevention
Food and Drug Administration
Board of Scientific Counselors,
National Center for Health Statistics
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Orphan Drugs
BILLING CODE 6730–01–P
FEDERAL MARITIME COMMISSION
Ocean Transportation Intermediary
License Applicants
Notice is hereby given that the
following applicants have filed with the
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application for license as a Non-Vessel
Operating Common Carrier and Ocean
Freight Forwarder—Ocean
Transportation Intermediary pursuant to
section 19 of the Shipping Act of 1984
as amended (46 U.S.C. Chapter 409 and
46 CFR part 515).
Persons knowing of any reason why
the following applicants should not
receive a license are requested to
contact the Office of Transportation
Intermediaries, Federal Maritime
Commission, Washington, DC 20573.
Non-Vessel Operating Common Carrier
Ocean Transportation Intermediary
Applicant
Jeepney Express Padala, Inc. dba
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Drive, Anaheim, CA 92801. Officers:
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jlentini on PROD1PC65 with NOTICES
Victoria Shipping, 104 Bald Knob Road,
Wetumpka, AL 36092. Susan V.
Hagan, Sole Proprietor.
Dated: August 24, 2007.
Karen V. Gregory,
Assistant Secretary.
[FR Doc. E7–17128 Filed 8–28–07; 8:45 am]
BILLING CODE 6730–01–P
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC), National
Center for Health Statistics (NCHS)
announces the following meeting of the
aforementioned committee.
Times and Dates: 2 p.m.–5:30 p.m.,
September 17, 2007. 8:30 a.m.–2 p.m.,
September 18, 2007.
Place: NCHS Headquarters, 3311 Toledo
Road, Hyattsville, Maryland 20782.
Status: Open to the public, and limited
only to the space available. The meeting
room accommodates approximately 100
people.
Purpose: This committee is charged with
providing advice and making
recommendations to the Secretary,
Department of Health and Human Services;
the Director, CDC; and the Director, NCHS,
regarding the scientific and technical
program goals and objectives, strategies, and
priorities of NCHS.
Matters To Be Discussed: The agenda will
include welcome remarks by the Director,
NCHS; introduction of new chair and new
members and key NCHS staff; data access
discussions; discussion of the upcoming
review of the SLAITS program; discussion of
upcoming program reviews and an open
session for comments from the public.
Requests to make oral presentations should
be submitted in writing to the contact person
listed below. All requests must contain the
name, address, telephone number, and
organizational affiliation of the presenter.
Written comments should not exceed five
single-spaced typed pages in length and must
be received by September 10, 2007.
The agenda items are subject to change as
priorities dictate.
For Further Information Contact: Virginia
S. Cain, Ph.D., Director of Extramural
Research, NCHS/CDC, 3311 Toledo Road,
Room 7211, Hyattsville, Maryland 20782,
telephone (301) 458–4500, fax (301) 458–
4020.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: August 22, 2007.
Elaine L. Baker,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E7–17137 Filed 8–28–07; 8:45 am]
BILLING CODE 4163–18–P
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[Docket No. 2006N–0420]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Orphan Drugs’’ has been approved by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
SUPPLEMENTARY INFORMATION: In the
Federal Register of May 29, 2007 (72 FR
29515), the agency announced that the
proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. 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 OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0167. The
approval expires on August 31, 2010. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
Dated: August 23, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–17094 Filed 8–28–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0310]
Companion to Guidance for Industry
on Pharmacogenomic Data;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
E:\FR\FM\29AUN1.SGM
29AUN1
Federal Register / Vol. 72, No. 167 / Wednesday, August 29, 2007 / Notices
jlentini on PROD1PC65 with NOTICES
availability of a draft guidance entitled
‘‘Pharmacogenomic Data Submissions—
Companion Guidance.’’ The guidance is
intended as a companion to the
guidance of the same name, which was
issued in 2005 (70 FR 14698; March 23,
2005). It reflects experience gained since
the issuance of that guidance with
voluntary genomic data submissions as
well as with review by FDA of
numerous protocols and data submitted
under investigational new drug (IND)
applications, new drug applications
(NDAs), and biologics license
applications (BLAs). The
recommendations are intended to
facilitate scientific progress in the field
of pharmacogenomics and to facilitate
the use of pharmacogenomic data in
drug development.
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 November 27, 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. Send one selfaddressed adhesive label to assist that
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 either https://
www.fda.gov/dockets/ecomments or
https://www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Federico Goodsaid, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 21, Rm. 3663,
Silver Spring, MD 20903–0002, 301–
796–1535.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance, which is intended to
be used as a companion to the guidance
issued in March 2005 entitled
‘‘Pharmacogenomic Data Submissions.’’
This draft guidance entitled
‘‘Pharmacogenomic Data Submissions—
Companion Guidance’’ is based on
FDA’s experience with voluntary
genomic data submissions as well as
VerDate Aug<31>2005
16:04 Aug 28, 2007
Jkt 211001
49723
with its review of numerous protocols
and data submitted under IND
applications, NDAs, and BLAs during
the last 2 years. FDA believes that the
recommendations in the draft guidance
will benefit sponsors considering the
submission of either voluntary genomic
data or marketing submissions
containing genomics data. As
technology changes and more
experience is gained, these
recommendations may be updated.
Specifically, this draft guidance
contains recommendations on gene
expression data from microarrays,
genotyping, genomic data in clinical
study reports, genomic data from
nonclinical toxicology studies, and data
submission formats. Each of the sections
in the guidance make recommendations
on technical steps or describes report
contents or formats that will facilitate
the submission of genomic data to FDA.
A concept paper containing the contents
of this draft guidance was made
available on the Genomics Web site of
FDA (https://www.fda.gov/cder/
genomics/conceptpaper_20061107.pdf)
on November 2006. The concept paper
was discussed at the FDA/Drug
Information Association/Pharmaceutical
Research and Manufacturers of America
Foundation/Biotechnology Industry
Organization workshop on Best
Practices and Development of Standards
for the Submission of Genomic Data to
FDA held in Washington, DC on
November 27 and 28, 2006. This draft
companion guidance reflects feedback
received at and since the workshop.
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 recommendations for the submission
and review of genomic data. 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.
FOR FURTHER INFORMATION CONTACT:
Paula Trumbo, Center for Food Safety
and Applied Nutrition (HFS–830), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
301–436–2579.
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.
In FR Doc.
E7–13274, appearing on page 37246 in
the Federal Register of Monday, July 9,
2007, the following corrections are
made:
1. On page 37246, in the second
column, in the ADDRESSES section, the
phrase ‘‘https://www/fda/gov/dockets/
ecomments’’ is corrected to read ‘‘https://
www.fda.gov/dockets/ecomments’’.
2. On page 37246, in the second
column, in the FOR FURTHER
INFORMATION CONTACT section, the
telephone number ‘‘310–436–2579’’ is
corrected to read ‘‘301–436–2579’’.
PO 00000
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III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm or https://www.fda.gov/
ohrms/dockets/default.htm.
Dated: August 23, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–17103 Filed 8–28–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0125]
Draft Guidance for Industry: EvidenceBased Review System for the Scientific
Evaluation of Health Claims;
Availability; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
SUMMARY: The Food and Drug
Administration is correcting a notice
that appeared in the Federal Register of
July 9, 2007 (72 FR 37246). The
document announced the availability
for public comment of a draft guidance
entitled ‘‘Guidance for Industry:
Evidence-Based Review System for the
Scientific Evaluation of Health Claims.’’
The document was published with an
incorrect Internet address for submitting
electronic comments and an incorrect
telephone number. This document
corrects those errors.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\29AUN1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 167 (Wednesday, August 29, 2007)]
[Notices]
[Pages 49722-49723]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-17103]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0310]
Companion to Guidance for Industry on Pharmacogenomic Data;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
[[Page 49723]]
availability of a draft guidance entitled ``Pharmacogenomic Data
Submissions--Companion Guidance.'' The guidance is intended as a
companion to the guidance of the same name, which was issued in 2005
(70 FR 14698; March 23, 2005). It reflects experience gained since the
issuance of that guidance with voluntary genomic data submissions as
well as with review by FDA of numerous protocols and data submitted
under investigational new drug (IND) applications, new drug
applications (NDAs), and biologics license applications (BLAs). The
recommendations are intended to facilitate scientific progress in the
field of pharmacogenomics and to facilitate the use of pharmacogenomic
data in drug development.
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 November 27, 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. Send one self-addressed adhesive label to
assist that 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 either https://www.fda.gov/
dockets/ecomments or https://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT: Federico Goodsaid, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 21, Rm. 3663, Silver Spring, MD 20903-0002, 301-
796-1535.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance, which is
intended to be used as a companion to the guidance issued in March 2005
entitled ``Pharmacogenomic Data Submissions.'' This draft guidance
entitled ``Pharmacogenomic Data Submissions--Companion Guidance'' is
based on FDA's experience with voluntary genomic data submissions as
well as with its review of numerous protocols and data submitted under
IND applications, NDAs, and BLAs during the last 2 years. FDA believes
that the recommendations in the draft guidance will benefit sponsors
considering the submission of either voluntary genomic data or
marketing submissions containing genomics data. As technology changes
and more experience is gained, these recommendations may be updated.
Specifically, this draft guidance contains recommendations on gene
expression data from microarrays, genotyping, genomic data in clinical
study reports, genomic data from nonclinical toxicology studies, and
data submission formats. Each of the sections in the guidance make
recommendations on technical steps or describes report contents or
formats that will facilitate the submission of genomic data to FDA. A
concept paper containing the contents of this draft guidance was made
available on the Genomics Web site of FDA (https://www.fda.gov/cder/
genomics/conceptpaper_20061107.pdf) on November 2006. The concept
paper was discussed at the FDA/Drug Information Association/
Pharmaceutical Research and Manufacturers of America Foundation/
Biotechnology Industry Organization workshop on Best Practices and
Development of Standards for the Submission of Genomic Data to FDA held
in Washington, DC on November 27 and 28, 2006. This draft companion
guidance reflects feedback received at and since the workshop.
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
recommendations for the submission and review of genomic data. 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.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/cder/guidance/index.htm or https://
www.fda.gov/ohrms/dockets/default.htm.
Dated: August 23, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-17103 Filed 8-28-07; 8:45 am]
BILLING CODE 4160-01-S
