Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records, 41504-41506 [2011-17675]
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41504
Federal Register / Vol. 76, No. 135 / Thursday, July 14, 2011 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
21 CFR Section
Number of records
per recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
58.35(b)(1) to (b)(6) and (c) .........................
58.63(b) and (c) ...........................................
58.81(a) to (c) ..............................................
58.90(c) and (g) ...........................................
58.105(a) and (b) .........................................
58.107(d) ......................................................
58.113(a) ......................................................
58.120 ..........................................................
58.195 ..........................................................
300
300
300
300
300
300
300
300
300
270.76
60
301.8
62.7
5
1
15.33
15.38
251.5
81,228
18,000
90,540
18,810
1,500
300
4,599
4,614
75,450
3.36
0.09
0.14
0.13
11.8
4.25
6.8
32.7
3.9
272,926
1,620
12,676
2,445
17,700
1,275
31,273
150,878
294,255
Total ......................................................
............................
..............................
............................
..............................
786,308
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651,
juanmanuel.vilela@fda.hhs.gov.
[FR Doc. 2011–17736 Filed 7–13–11; 8:45 am]
BILLING CODE 4160–01–P
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:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Adverse Experience Reporting For
Licensed Biological Products; and
General Records—21 CFR Part 600
(OMB Control Number 0910–0308)—
Extension
[Docket No. FDA–2011–N–0231]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Adverse
Experience Reporting for Licensed
Biological Products; and General
Records
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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.
DATES: Fax written comments on the
collection of information by August 15,
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 e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0308. Also
include the FDA docket number found
in brackets in the heading of this
document.
wreier-aviles on DSKGBLS3C1PROD with NOTICES
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
VerDate Mar<15>2010
14:55 Jul 13, 2011
Jkt 223001
Under the Public Health Service Act
(42 U.S.C. 262), FDA may only approve
a biologics license application for a
biological product that is safe, pure, and
potent. When a biological product is
approved and enters the market, the
product is introduced to a larger patient
population in settings different from
clinical trials. New information
generated during the postmarketing
period offers further insight into the
benefits and risks of the product, and
evaluation of this information is
important to insure its safe use. FDA
issued the Adverse Experience
Reporting (AER) requirements in part
600 (21 CFR part 600) to enable FDA to
take actions necessary for the protection
of the public health in response to
reports of adverse experiences related to
licensed biological products. The
primary purpose of FDA’s AER system
is to identify potentially serious safety
problems with licensed biological
products. Although premarket testing
discloses a general safety profile of a
biological product’s comparatively
common adverse effects, the larger and
more diverse patient populations
exposed to the licensed biological
product provides the opportunity to
collect information on rare, latent, and
long-term effects. In addition,
production and/or distribution
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
problems have contaminated biological
products in the past. AER reports are
obtained from a variety of sources,
including manufacturers, patients,
physicians, foreign regulatory Agencies,
and clinical investigators. Identification
of new and unexpected safety issues
through the analysis of the data in the
AER system contributes directly to
increased public health protection. For
example, evaluation of these safety
issues enables FDA to take focused
regulatory action. Such action may
include, but is not limited to, important
changes to the product’s labeling (such
as adding a new warning), coordination
with manufacturers to ensure adequate
corrective action is taken, and removal
of a biological product from the market
when necessary.
Section 600.80(c)(1) requires licensed
manufacturers or any person whose
name appears on the label of a licensed
biological product to report each
adverse experience that is both serious
and unexpected, whether foreign or
domestic, as soon as possible but in no
case later than 15 calendar days of
initial receipt of the information by the
licensed manufacturer. These reports
are known as postmarketing 15-day alert
reports. This section also requires
licensed manufacturers to submit any
followup reports within 15 calendar
days of receipt of new information or as
requested by FDA, and if additional
information is not obtainable to
maintain records of the unsuccessful
steps taken to seek additional
information. In addition, this section
requires a person who submits an
adverse action report to the licensed
manufacturer rather than FDA to
maintain a record of this action. Section
600.80(e) requires licensed
manufacturers to submit a 15-day alert
report for an adverse experience
obtained from a postmarketing clinical
study only if the licensed manufacturer
concludes that there is a reasonable
possibility that the product caused the
E:\FR\FM\14JYN1.SGM
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Federal Register / Vol. 76, No. 135 / Thursday, July 14, 2011 / Notices
adverse experience. Section 600.80(c)(2)
requires licensed manufacturers to
report each adverse experience not
reported in a postmarketing 15-day alert
report at quarterly intervals, for 3 years
from the date of issuance of the
biologics license, and then at annual
intervals. The majority of these periodic
reports are submitted annually since a
large percentage of currently licensed
biological products have been licensed
longer than 3 years. Section 600.80(i)
requires licensed manufacturers to
maintain for a period of 10 years records
of all adverse experiences known to the
licensed manufacturer, including raw
data and any correspondence relating to
the adverse experiences. Section 600.81
requires licensed manufacturers to
submit, at an interval of every 6 months,
information about the quantity of the
product distributed under the biologics
license, including the quantity
distributed to distributors. These
distribution reports provide FDA with
important information about products
distributed under biologics licenses,
including the quantity, certain lot
numbers, labeled date of expiration, the
fill lot numbers for the total number of
dosage units of each strength or potency
distributed (e.g., 50,000 per 10-milliliter
vials), and date of release. FDA may
require the licensed manufacturer to
submit distribution reports under this
section at times other than every 6
months. Under § 600.90, a licensed
manufacturer may submit a waiver
request for any requirements that apply
to the licensed manufacturer under
§§ 600.80 and 600.81. A waiver request
submitted under § 600.90 must include
supporting documentation.
Manufacturers of biological products
for human use must keep records of
each step in the manufacture and
distribution of a product including any
recalls. These recordkeeping
requirements serve preventative and
remedial purposes by establishing
accountability and traceability in the
manufacture and distribution of
products. These requirements also
enable FDA to perform meaningful
inspections. Section 600.12 requires,
among other things, that records must
be made, concurrently with the
performance of each step in the
manufacture and distribution of
products. These records must be
retained for no less than 5 years after the
records of manufacture have been
completed or 6 months after the latest
expiration date for the individual
product, whichever represents a later
date. In addition, under § 600.12,
manufacturers must maintain records
relating to the sterilization of equipment
and supplies, animal necropsy records,
and records in cases of divided
manufacturing responsibility with
respect to a product. Under
§ 600.12(b)(2), manufacturers are also
required to maintain complete records
pertaining to the recall from distribution
of any product. Furthermore, § 610.18(b)
(21 CFR 610.18(b)) requires, in part, that
the results of all periodic tests for
verification of cultures and
determination of freedom from
extraneous organisms be recorded and
maintained.
Respondents to this collection of
information include manufacturers of
biological products and any person
whose name appears on the label of a
licensed biological product. Under table
1 of this document, the number of
respondents is based on the estimated
number of manufacturers that are
subject to those regulations or that
submitted the required information to
the Center for Biologics Evaluation and
Research and Center for Drugs
Evaluation and Research, FDA, in fiscal
year (FY) 2010. Based on information
obtained from the FDA’s database
system, there were 108 licensed
biologics manufacturers. This number
excludes those manufacturers who
produce Whole Blood or components of
Whole Blood and in vitro diagnostic
licensed products, because of the
exemption under § 600.80(k). The total
annual responses are based on the
number of submissions received by FDA
in FY 2010. There were an estimated
86,583 15-day Alert reports, 57,300
periodic reports, and 349 lot
distribution reports submitted to FDA.
The number of 15-day alert reports for
post marketing studies under § 600.80(e)
is included in the total number of 15day alert reports. FDA received 21
requests for waivers under § 600.90, of
which 19 were granted. The hours per
response are based on FDA experience.
The burden hours required to complete
the MedWatch Form for § 600.80(c)(1),
(e), and (f) are reported under OMB
control number 0910–0291.
In the Federal Register of April 21,
2011 (77 FR 22401), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received from the public.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
600.80(c)(1) and 600.80(e) ................................................
600.80(c)(2) ........................................................................
600.81 ................................................................................
600.90 ................................................................................
108
108
108
21
801.69
530.55
3.23
1
86,583
57,300
349
21
1
28
1
1
86,583
1,604,400
349
21
Total ............................................................................
........................
..........................
........................
........................
1,691,353
wreier-aviles on DSKGBLS3C1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Under table 2 of this document, the
number of respondents is based on the
number of manufacturers subject to
those regulations. Based on information
obtained from FDA’s database system,
there were 304 licensed manufacturers
of biological products in FY 2010.
However, the number of recordkeepers
VerDate Mar<15>2010
14:55 Jul 13, 2011
Jkt 223001
listed for § 600.12(a) through (e)
excluding (b)(2) is estimated to be 131.
This number excludes manufacturers of
blood and blood components because
their burden hours for recordkeeping
have been reported under § 606.160 in
OMB control number 0910–0116. The
total annual records is based on the
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
annual average of lots released in FY
2010 (6,752), number of recalls made
(1,881), and total number of adverse
experience reports received (143,883) in
FY 2010. The hours per record are based
on FDA experience.
FDA estimates the burden of this
recordkeeping as follows:
E:\FR\FM\14JYN1.SGM
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Federal Register / Vol. 76, No. 135 / Thursday, July 14, 2011 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
600.12 2 ..............................................................................
600.12 (b)(2) ......................................................................
600.80(c)(1) and 600.80(i) .................................................
131
304
108
51.54
6.19
1,332.25
6,752
1,881
143,883
32
24
1
216,064
45,144
143,883
Total ............................................................................
........................
..........................
........................
........................
405,091
1 There
2 The
are no capital costs or operating and maintenance costs associated with this collection of information.
recordkeeping requirements in § 610.18(b) are included in the estimate for § 600.12.
Dated: July 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–17675 Filed 7–13–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0215]
Draft Guidance for Industry and FDA
Staff on In Vitro Companion Diagnostic
Devices; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘In Vitro Companion Diagnostic
Devices.’’ This guidance is intended to
assist sponsors planning to develop a
therapeutic product that depends on the
use of an in vitro companion diagnostic
device for its safe and effective use or
an in vitro diagnostic device that is
intended for use with a corresponding
therapeutic product and included in the
instructions for use in the labeling of
those products. This guidance defines in
vitro companion diagnostic devices;
explains the need for FDA oversight of
companion diagnostic devices; clarifies
that, in most circumstances, if use of a
companion diagnostic device is
essential for the safe and effective use of
a therapeutic product, the diagnostic
device and therapeutic product should
be approved or cleared
contemporaneously by FDA for the use
indicated in the therapeutic product
labeling; provides guidance for industry
and FDA staff on possible premarket
regulatory pathways and FDA’s
regulatory enforcement policy; and
describes certain statutory and
regulatory approval requirements
relevant to therapeutic product labeling
that stipulate concomitant use of a
companion diagnostic device to ensure
wreier-aviles on DSKGBLS3C1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
14:55 Jul 13, 2011
Jkt 223001
safety and effectiveness of the
therapeutic product. This draft guidance
is not final, nor is it in effect at this
time.
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
either electronic or written comments
on the draft guidance by September 12,
2011.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘In Vitro Companion
Diagnostic Devices’’ to the Division of
Small Manufacturers, 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 a
fax request to 301–827–8149 to receive
a hard copy. Alternatively, you may
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 Office
of Communication, Outreach and
Development (HFM–40), 1401 Rockville
Pike, suite 200N, Rockville, MD 20852.
Send one self-addressed adhesive label
to the office that you are ordering from
to assist in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for information on electronic access to
the guidance.
Submit electronic comments on the
draft 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:
Elizabeth Mansfield, Center for Devices
and Radiologic Health, Food and Drug
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
Administration, Bldg. 66, rm. 5676,
10903 New Hampshire Ave., Silver
Spring, MD 20993, 301–796–4664; or
Christopher Leptak, Office of
Translational Sciences, Center for Drug
Evaluation and Research, Food and
Drug Administration, Bldg. 22, rm.
5102, 10903 New Hampshire Ave.,
Silver Spring, MD 20993, 301–796–
0017; or Stephen Ripley, Center for
Biologics Evaluation and Research
(HFM–17), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852, 301–
827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
The Food and Drug Administration
(FDA) is announcing the availability of
a draft guidance for industry and FDA
staff entitled ‘‘In Vitro Companion
Diagnostic Devices.’’ This guidance is
intended to provide assistance both to
sponsors developing therapeutic
products, which for purposes of this
guidance includes therapeutic,
preventive, or prophylactic drugs and
biological products that depend on the
use of and are labeled for use with an
in vitro diagnostic device, and to
sponsors of the companion diagnostics.
This guidance defines ‘‘companion
diagnostic device’’ and clarifies that in
most circumstances, if use of a
companion diagnostic device is
essential for the safe and effective use of
a therapeutic product, the diagnostic
device and therapeutic product should
be approved or cleared
contemporaneously by FDA for the use
indicated in the therapeutic product
labeling.
Diagnostic tests have been employed
for many years to enhance the use of
therapeutic products. Recently,
therapeutic products that depend on the
use of a diagnostic test to meet their
labeled safety and effectiveness claims
have become more common. For
example, a test could identify or limit
appropriate populations for treatment or
identify populations who should not
receive a particular treatment because of
E:\FR\FM\14JYN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 135 (Thursday, July 14, 2011)]
[Notices]
[Pages 41504-41506]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17675]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0231]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Adverse Experience
Reporting for Licensed Biological Products; and General Records
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 August
15, 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 e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0308.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-7651,
juanmanuel.vilela@fda.hhs.gov.
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.
Adverse Experience Reporting For Licensed Biological Products; and
General Records--21 CFR Part 600 (OMB Control Number 0910-0308)--
Extension
Under the Public Health Service Act (42 U.S.C. 262), FDA may only
approve a biologics license application for a biological product that
is safe, pure, and potent. When a biological product is approved and
enters the market, the product is introduced to a larger patient
population in settings different from clinical trials. New information
generated during the postmarketing period offers further insight into
the benefits and risks of the product, and evaluation of this
information is important to insure its safe use. FDA issued the Adverse
Experience Reporting (AER) requirements in part 600 (21 CFR part 600)
to enable FDA to take actions necessary for the protection of the
public health in response to reports of adverse experiences related to
licensed biological products. The primary purpose of FDA's AER system
is to identify potentially serious safety problems with licensed
biological products. Although premarket testing discloses a general
safety profile of a biological product's comparatively common adverse
effects, the larger and more diverse patient populations exposed to the
licensed biological product provides the opportunity to collect
information on rare, latent, and long-term effects. In addition,
production and/or distribution problems have contaminated biological
products in the past. AER reports are obtained from a variety of
sources, including manufacturers, patients, physicians, foreign
regulatory Agencies, and clinical investigators. Identification of new
and unexpected safety issues through the analysis of the data in the
AER system contributes directly to increased public health protection.
For example, evaluation of these safety issues enables FDA to take
focused regulatory action. Such action may include, but is not limited
to, important changes to the product's labeling (such as adding a new
warning), coordination with manufacturers to ensure adequate corrective
action is taken, and removal of a biological product from the market
when necessary.
Section 600.80(c)(1) requires licensed manufacturers or any person
whose name appears on the label of a licensed biological product to
report each adverse experience that is both serious and unexpected,
whether foreign or domestic, as soon as possible but in no case later
than 15 calendar days of initial receipt of the information by the
licensed manufacturer. These reports are known as postmarketing 15-day
alert reports. This section also requires licensed manufacturers to
submit any followup reports within 15 calendar days of receipt of new
information or as requested by FDA, and if additional information is
not obtainable to maintain records of the unsuccessful steps taken to
seek additional information. In addition, this section requires a
person who submits an adverse action report to the licensed
manufacturer rather than FDA to maintain a record of this action.
Section 600.80(e) requires licensed manufacturers to submit a 15-day
alert report for an adverse experience obtained from a postmarketing
clinical study only if the licensed manufacturer concludes that there
is a reasonable possibility that the product caused the
[[Page 41505]]
adverse experience. Section 600.80(c)(2) requires licensed
manufacturers to report each adverse experience not reported in a
postmarketing 15-day alert report at quarterly intervals, for 3 years
from the date of issuance of the biologics license, and then at annual
intervals. The majority of these periodic reports are submitted
annually since a large percentage of currently licensed biological
products have been licensed longer than 3 years. Section 600.80(i)
requires licensed manufacturers to maintain for a period of 10 years
records of all adverse experiences known to the licensed manufacturer,
including raw data and any correspondence relating to the adverse
experiences. Section 600.81 requires licensed manufacturers to submit,
at an interval of every 6 months, information about the quantity of the
product distributed under the biologics license, including the quantity
distributed to distributors. These distribution reports provide FDA
with important information about products distributed under biologics
licenses, including the quantity, certain lot numbers, labeled date of
expiration, the fill lot numbers for the total number of dosage units
of each strength or potency distributed (e.g., 50,000 per 10-milliliter
vials), and date of release. FDA may require the licensed manufacturer
to submit distribution reports under this section at times other than
every 6 months. Under Sec. 600.90, a licensed manufacturer may submit
a waiver request for any requirements that apply to the licensed
manufacturer under Sec. Sec. 600.80 and 600.81. A waiver request
submitted under Sec. 600.90 must include supporting documentation.
Manufacturers of biological products for human use must keep
records of each step in the manufacture and distribution of a product
including any recalls. These recordkeeping requirements serve
preventative and remedial purposes by establishing accountability and
traceability in the manufacture and distribution of products. These
requirements also enable FDA to perform meaningful inspections. Section
600.12 requires, among other things, that records must be made,
concurrently with the performance of each step in the manufacture and
distribution of products. These records must be retained for no less
than 5 years after the records of manufacture have been completed or 6
months after the latest expiration date for the individual product,
whichever represents a later date. In addition, under Sec. 600.12,
manufacturers must maintain records relating to the sterilization of
equipment and supplies, animal necropsy records, and records in cases
of divided manufacturing responsibility with respect to a product.
Under Sec. 600.12(b)(2), manufacturers are also required to maintain
complete records pertaining to the recall from distribution of any
product. Furthermore, Sec. 610.18(b) (21 CFR 610.18(b)) requires, in
part, that the results of all periodic tests for verification of
cultures and determination of freedom from extraneous organisms be
recorded and maintained.
Respondents to this collection of information include manufacturers
of biological products and any person whose name appears on the label
of a licensed biological product. Under table 1 of this document, the
number of respondents is based on the estimated number of manufacturers
that are subject to those regulations or that submitted the required
information to the Center for Biologics Evaluation and Research and
Center for Drugs Evaluation and Research, FDA, in fiscal year (FY)
2010. Based on information obtained from the FDA's database system,
there were 108 licensed biologics manufacturers. This number excludes
those manufacturers who produce Whole Blood or components of Whole
Blood and in vitro diagnostic licensed products, because of the
exemption under Sec. 600.80(k). The total annual responses are based
on the number of submissions received by FDA in FY 2010. There were an
estimated 86,583 15-day Alert reports, 57,300 periodic reports, and 349
lot distribution reports submitted to FDA. The number of 15-day alert
reports for post marketing studies under Sec. 600.80(e) is included in
the total number of 15-day alert reports. FDA received 21 requests for
waivers under Sec. 600.90, of which 19 were granted. The hours per
response are based on FDA experience. The burden hours required to
complete the MedWatch Form for Sec. 600.80(c)(1), (e), and (f) are
reported under OMB control number 0910-0291.
In the Federal Register of April 21, 2011 (77 FR 22401), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received from the public.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
600.80(c)(1) and 600.80(e)...... 108 801.69 86,583 1 86,583
600.80(c)(2).................... 108 530.55 57,300 28 1,604,400
600.81.......................... 108 3.23 349 1 349
600.90.......................... 21 1 21 1 21
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,691,353
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Under table 2 of this document, the number of respondents is based
on the number of manufacturers subject to those regulations. Based on
information obtained from FDA's database system, there were 304
licensed manufacturers of biological products in FY 2010. However, the
number of recordkeepers listed for Sec. 600.12(a) through (e)
excluding (b)(2) is estimated to be 131. This number excludes
manufacturers of blood and blood components because their burden hours
for recordkeeping have been reported under Sec. 606.160 in OMB control
number 0910-0116. The total annual records is based on the annual
average of lots released in FY 2010 (6,752), number of recalls made
(1,881), and total number of adverse experience reports received
(143,883) in FY 2010. The hours per record are based on FDA experience.
FDA estimates the burden of this recordkeeping as follows:
[[Page 41506]]
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
600.12 \2\...................... 131 51.54 6,752 32 216,064
600.12 (b)(2)................... 304 6.19 1,881 24 45,144
600.80(c)(1) and 600.80(i)...... 108 1,332.25 143,883 1 143,883
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Total....................... .............. .............. .............. .............. 405,091
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ The recordkeeping requirements in Sec. 610.18(b) are included in the estimate for Sec. 600.12.
Dated: July 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-17675 Filed 7-13-11; 8:45 am]
BILLING CODE 4160-01-P
