Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Pharmacogenomic Data Submissions; Extension, 6621-6622 [2011-2637]
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6621
Federal Register / Vol. 76, No. 25 / Monday, February 7, 2011 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN
[Registered licensed mixer-feeders] 1
Number of
recordkeepers
Annual
frequency per
recordkeeping
225.42(b)(5) through (b)(8) ................................................
225.58(c) and (d) ...............................................................
225.80(b)(2) .......................................................................
225.102(b)(1) .....................................................................
100
100
100
100
260
36
48
260
26,000
3,600
4,800
26,000
.15
.5
.12
.4
3,900
1,800
576
10,400
Total ............................................................................
........................
........................
........................
..........................
16,676
21 CFR section
1 There
Total annual
records
Hours per
record
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN
[Nonregistered unlicensed commercial feed mills) 1
Number of
recordkeepers
Annual
frequency per
recordkeeping
..............................................................................
..............................................................................
..............................................................................
..............................................................................
8,000
8,000
8,000
8,000
4
1
96
260
32,000
8,000
768,000
2,080,000
1
4
.12
.65
32,000
32,000
92,160
1,352,000
Total ............................................................................
........................
........................
........................
..........................
1,508,160
21 CFR section
225.142
225.158
225.180
225.202
1 There
Total annual
records
Hours per
record
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN
[Nonregistered unlicensed mixer-feeders] 1
Number of
recordkeepers
Annual
frequency per
recordkeeping
..............................................................................
..............................................................................
..............................................................................
..............................................................................
45,000
45,000
45,000
45,000
4
1
32
260
180,000
45,000
1,440,000
11,700,000
1
4
.12
.33
180,000
180,000
172,800
3,861,000
Total ............................................................................
........................
........................
........................
..........................
4,393,800
21 CFR section
225.142
225.158
225.180
225.202
1 There
Hours per
record
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of the times required for
record preparation and maintenance is
based on Agency communications with
industry. Other information needed to
finally calculate the total burden hours
(i.e., number of recordkeepers, number
of medicated feeds being manufactured,
etc.) is derived from Agency records and
experience.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0536]
Dated: February 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Pharmacogenomic Data
Submissions; Extension
[FR Doc. 2011–2548 Filed 2–4–11; 8:45 am]
AGENCY:
BILLING CODE 4160–01–P
emcdonald on DSK2BSOYB1PROD with NOTICES
Total annual
records
HHS.
ACTION:
Food and Drug Administration,
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
VerDate Mar<15>2010
17:16 Feb 04, 2011
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Fax written comments on the
collection of information by March 9,
2011.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0557. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
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.
E:\FR\FM\07FEN1.SGM
07FEN1
6622
Federal Register / Vol. 76, No. 25 / Monday, February 7, 2011 / Notices
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Guidance for Industry on
Pharmacogenomic Data Submissions—
(OMB Control Number 0910–0557)—
Extension
The guidance provides
recommendations to sponsors
submitting or holding investigational
new drug applications (INDs), new drug
applications (NDAs), or biologics
license applications (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 (21 CFR 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 decisionmaking, 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.
In the Federal Register of November
4, 2010 (75 FR 67983), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received on the information collection.
FDA estimates the burden of this
collection of information as follows:
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 ................................
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–2637 Filed 2–4–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0645]
emcdonald on DSK2BSOYB1PROD with NOTICES
Guidance for Industry and Food and
Drug Administration Staff; Class II
Special Controls Guidance Document:
Contact Cooling System for Aesthetic
Use; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Class II Special Controls Guidance
SUMMARY:
17:16 Feb 04, 2011
Submit electronic or written
comments on the guidance at any time.
General comments on Agency guidance
are welcome at any time.
DATES:
Submit written requests for
single copies of the guidance document
entitled ‘‘Class II Special Controls
Guidance Document: Contact Cooling
System for Aesthetic Use’’ to the
Division of Small Manufacturers,
ADDRESSES:
Notice.
VerDate Mar<15>2010
Document: Contact Cooling System for
Aesthetic Use.’’ This guidance document
describes a means by which contact
cooling systems for aesthetic use may
comply with the requirement of special
controls for class II devices. Elsewhere
in this issue of the Federal Register,
FDA is publishing a final rule to classify
contact cooling systems for aesthetic use
into class II (special controls). The
guidance document is immediately in
effect as the special control for cooling
system for aesthetic use, but it remains
subject to comment in accordance with
the Agency’s good guidance practices
(GGPs).
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International, and Consumer Assistance,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
rm. 4613, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request, or fax your request to 301–
847–8149. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Richard Felten, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1436, Silver Spring,
MD 20993–0002, 301–796–6392.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\07FEN1.SGM
07FEN1
]]>Agencies
[Federal Register Volume 76, Number 25 (Monday, February 7, 2011)]
[Notices]
[Pages 6621-6622]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2637]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0536]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by March
9, 2011.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0557.
Also include the FDA 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.
[[Page 6622]]
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Guidance for Industry on Pharmacogenomic Data Submissions--(OMB Control
Number 0910-0557)--Extension
The guidance provides recommendations to sponsors submitting or
holding investigational new drug applications (INDs), new drug
applications (NDAs), or biologics license applications (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 (21 CFR 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
decisionmaking, 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.
In the Federal Register of November 4, 2010 (75 FR 67983), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received on the information
collection.
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................................. 7 1 7 50 350
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-2637 Filed 2-4-11; 8:45 am]
BILLING CODE 4160-01-P
