Agency Information Collection Activities: Proposed Collection; Comment Request, Guidance for Industry on Pharmacogenomic Data Submissions; Extension, 67983-67984 [2010-27847]
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Federal Register / Vol. 75, No. 213 / Thursday, November 4, 2010 / Notices
Dated: October 25, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
67983
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FR Doc. 2010–27850 Filed 11–3–10; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0536]
BILLING CODE 4160–01–P
[Docket No. FDA–2009–N–0098]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Evaluation of Potential Data Sources
for the Sentinel Initiative
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0190]
AGENCY:
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Infant Formula Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Infant Formula Requirements’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Johnny Vilela, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7651, e-mail:
Juanmanuel.Vilela@fda.hhs.gov.
In the
Federal Register of August 10, 2010 (75
FR 48350), 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 0910–0256. The
approval expires on October 31, 2013. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
jlentini on DSKJ8SOYB1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: October 25, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Evaluation of Potential Data Sources for
the Sentinel Initiative’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794,
Jonnalynn.capezzuto@fda.hhs.gov.
In the
Federal Register of September 4, 2009
(74 FR 45858), 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 0910–0657. The
approval expires on February 28, 2013.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: October 25, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–27848 Filed 11–3–10; 8:45 am]
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AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection resulting
from recommendations to sponsors
submitting or holding investigational
new drug applications (INDs), new drug
applications (NDAs), or biologic
licensing applications (BLAs) on what
pharmacogenomic data should be
submitted to the agency during the drug
development process.
DATES: Submit either electronic or
written comments on the collection of
information by January 3, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850,
301–796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined in
SUMMARY:
Notice.
[FR Doc. 2010–27849 Filed 11–3–10; 8:45 am]
VerDate Mar<15>2010
Agency Information Collection
Activities: Proposed Collection;
Comment Request, Guidance for
Industry on Pharmacogenomic Data
Submissions; Extension
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67984
Federal Register / Vol. 75, No. 213 / Thursday, November 4, 2010 / Notices
44 U.S.C. 3502(3) and 5 CFR 1320.3(c)
and includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires Federal agencies
to provide a 60-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and
(4) ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
other, less well-developed exploratory
tests. The submission of exploratory
pharmacogenomic data is not required
under the regulations, although the
agency encourages the voluntary
submission of such data.
The guidance describes the voluntary
genomic data submission (VGDS) that
can be used for such a voluntary
submission. The guidance does not
recommend a specific format for the
VGDS, except that such a voluntary
submission be designated as a VGDS.
The data submitted in a VGDS and the
level of detail should be sufficient for
FDA to be able to interpret the
information and independently analyze
the data, verify results, and explore
possible genotype-phenotype
correlations across studies. FDA does
not want the VGDS to be overly
burdensome and time-consuming for the
sponsor.
FDA has estimated the burden of
preparing a voluntary submission
described in the guidance that should be
designated as a VGDS. Based on FDA’s
experience with this guidance over the
past few years, and on FDA’s familiarity
with sponsors’ interest in submitting
pharmacogenomic data during the drug
development process, FDA estimates
that approximately seven sponsors will
submit approximately one VGDS and
that, on average, each VGDS will take
approximately 50 hours to prepare and
submit to FDA.
FDA estimates the burden of this
collection of information as follows:
Guidance for Industry on
Pharmacogenomic Data Submissions
(OMB Control Number 0910–0557—
Extension)
The guidance provides
recommendations to sponsors
submitting or holding INDs, NDAs, or
BLAs on what pharmacogenomic data
should be submitted to the agency
during the drug development process.
Sponsors holding and applicants
submitting INDs, NDAs, or BLAs are
subject to FDA requirements for
submitting to the agency data relevant to
drug safety and efficacy (§§ 312.22,
312.23, 312.31, 312.33, 314.50, 314.81,
601.2, and 601.12).
The guidance interprets FDA
regulations for IND, NDA, or BLA
submissions, clarifying when the
regulations require pharmacogenomics
data to be submitted and when the
submission of such data is voluntary.
The pharmacogenomic data submissions
described in the guidance that are
required to be submitted to an IND,
NDA, BLA, or annual report are covered
by the information collection
requirements under parts 312, 314, and
601 (21 CFR parts 312, 314, and 601)
and are approved by OMB under control
numbers 0910–0014 (part 312—INDs);
0910–0001 (part 314—NDAs and annual
reports); and 0910–0338 (part 601—
BLAs).
The guidance distinguishes between
pharmacogenomic tests that may be
considered valid biomarkers appropriate
for regulatory decision-making, and
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Annual
frequency
per
response
Total annual
responses
Hours per
response
Total hours
7
1
7
50
350
Voluntary Genomic Data Submissions Total .......................
1 There
are no capital costs or operating and maintenance costs associated with this collection.
Dated: October 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–27847 Filed 11–3–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0381]
jlentini on DSKJ8SOYB1PROD with NOTICES
Generic Drug User Fee; Notice of
Public Meeting; Reopening of the
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice; reopening of the
comment period.
ACTION:
The Food and Drug
Administration (FDA) is reopening until
December 6, 2010, the comment period
SUMMARY:
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16:47 Nov 03, 2010
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for the notice of public meeting entitled
Generic Drug User Fee; Public Meeting;
Request for Comments, published in the
Federal Register of August 9, 2010 (75
FR 47820). In that notice, FDA
announced a public meeting that took
place on September 17, 2010, to gather
stakeholder input on the development
of a generic drug user fee program. FDA
is reopening the comment period to
permit public consideration of latereceived comments and to provide an
opportunity for all interested parties to
provide information and share views on
the matter.
Submit either electronic or
written comments by December 6, 2010.
DATES:
E:\FR\FM\04NON1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 213 (Thursday, November 4, 2010)]
[Notices]
[Pages 67983-67984]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-27847]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0536]
Agency Information Collection Activities: Proposed Collection;
Comment Request, Guidance for Industry on Pharmacogenomic Data
Submissions; Extension
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
resulting from recommendations to sponsors submitting or holding
investigational new drug applications (INDs), new drug applications
(NDAs), or biologic licensing applications (BLAs) on what
pharmacogenomic data should be submitted to the agency during the drug
development process.
DATES: Submit either electronic or written comments on the collection
of information by January 3, 2011.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3792,
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in
[[Page 67984]]
44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information, including each proposed extension of an
existing collection of information, before submitting the collection to
OMB for approval. To comply with this requirement, FDA is publishing
notice of the proposed collection of information set forth in this
document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Guidance for Industry on Pharmacogenomic Data Submissions (OMB Control
Number 0910-0557--Extension)
The guidance provides recommendations to sponsors submitting or
holding INDs, NDAs, or BLAs on what pharmacogenomic data should be
submitted to the agency during the drug development process. Sponsors
holding and applicants submitting INDs, NDAs, or BLAs are subject to
FDA requirements for submitting to the agency data relevant to drug
safety and efficacy (Sec. Sec. 312.22, 312.23, 312.31, 312.33, 314.50,
314.81, 601.2, and 601.12).
The guidance interprets FDA regulations for IND, NDA, or BLA
submissions, clarifying when the regulations require pharmacogenomics
data to be submitted and when the submission of such data is voluntary.
The pharmacogenomic data submissions described in the guidance that are
required to be submitted to an IND, NDA, BLA, or annual report are
covered by the information collection requirements under parts 312,
314, and 601 (21 CFR parts 312, 314, and 601) and are approved by OMB
under control numbers 0910-0014 (part 312--INDs); 0910-0001 (part 314--
NDAs and annual reports); and 0910-0338 (part 601--BLAs).
The guidance distinguishes between pharmacogenomic tests that may
be considered valid biomarkers appropriate for regulatory decision-
making, and other, less well-developed exploratory tests. The
submission of exploratory pharmacogenomic data is not required under
the regulations, although the agency encourages the voluntary
submission of such data.
The guidance describes the voluntary genomic data submission (VGDS)
that can be used for such a voluntary submission. The guidance does not
recommend a specific format for the VGDS, except that such a voluntary
submission be designated as a VGDS. The data submitted in a VGDS and
the level of detail should be sufficient for FDA to be able to
interpret the information and independently analyze the data, verify
results, and explore possible genotype-phenotype correlations across
studies. FDA does not want the VGDS to be overly burdensome and time-
consuming for the sponsor.
FDA has estimated the burden of preparing a voluntary submission
described in the guidance that should be designated as a VGDS. Based on
FDA's experience with this guidance over the past few years, and on
FDA's familiarity with sponsors' interest in submitting pharmacogenomic
data during the drug development process, FDA estimates that
approximately seven sponsors will submit approximately one VGDS and
that, on average, each VGDS will take approximately 50 hours to prepare
and submit to FDA.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
Number of frequency per Total annual Hours per Total hours
respondents response responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Voluntary Genomic Data Submissions Total........................... 7 1 7 50 350
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection.
Dated: October 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-27847 Filed 11-3-10; 8:45 am]
BILLING CODE 4160-01-P
