Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records, 64392-64394 [2014-25637]
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64392
Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Notices
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014–25684 Filed 10–28–14; 8:45 am]
BILLING CODE 4184–01–P
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.
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 November
28, 2014.
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:
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:21 Oct 28, 2014
Jkt 235001
202–395–7285, or emailed 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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
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
(PHS) 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.1
The primary purpose of FDA’s AER
system is to identify potentially serious
safety problems with licensed biological
products. Although the premarket
approval process is meant to disclose 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,
1 Please note that throughout the regulations
referenced in relation to these information
collections, licensed biological products refers to
biologics licensed under any provision of section
351 of the PHS Act.
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
physicians, foreign regulatory agencies,
and clinical investigators. Identification
of new and unexpected safety issues
through the analysis of the data in AERS
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
follow-up 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
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
E:\FR\FM\29OCN1.SGM
29OCN1
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Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Notices
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 10milliliter 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)
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. The recordkeeping
requirements for §§ 610.12(g),
610.13(a)(2), 610.18(d), 680.2(f) and
680.3(f) are approved under OMB
control number 0910–0139.
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. In table 1,
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) 2013. Based on information
obtained from FDA’s database system,
there were 131 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
2013. There were an estimated 92,470
15-day Alert reports, 132,667 periodic
reports, and 334 lot distribution reports
submitted to FDA. The number of 15day Alert reports for postmarketing
studies under § 600.80(e) is included in
the total number of 15-day Alert reports.
FDA received 64 requests from 35
manufacturers for waivers under
§ 600.90, of which 63 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 7,
2014 (79 FR 19097), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received one
comment; however, this comment did
not address the information collection.
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 ..................................................................................
131
131
131
35
705.88
1,012.73
2.55
1.83
92,470
132,667
334
64
1
28
1
1
92,470
3,714,676
334
64
Total ..............................................................................
........................
........................
........................
........................
3,807,544
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
mstockstill on DSK4VPTVN1PROD with NOTICES
In table 2, 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 334 licensed manufacturers
of biological products in FY 2013.
However, the number of recordkeepers
listed for § 600.12(a) through (e)
excluding (b)(2) is estimated to be 164.
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
annual average of lots released in FY
2013 (6,887), number of recalls made
(1,679), and total number of adverse
experience reports received (225,137) in
FY 2013. The hours per record are based
on FDA experience.
FDA estimates the burden of this
recordkeeping as follows:
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
600.12 2 ................................................................................
600.12(b)(2) .........................................................................
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Frm 00037
Number of
records per
recordkeeper
164
334
Fmt 4703
Sfmt 4703
Total annual
records
41.99
5.03
E:\FR\FM\29OCN1.SGM
6,887
1,679
29OCN1
Average
burden per
recordkeeping
32
24
Total hours
220,384
40,296
64394
Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / 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
600.80(c)(1) and 600.80(i) ...................................................
131
1,718.60
225,137
1
225,137
Total ..............................................................................
........................
........................
........................
........................
485,817
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: October 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
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:
[FR Doc. 2014–25637 Filed 10–28–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1009]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Information
Request Regarding pH of Smokeless
Tobacco Products
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 November
28, 2014.
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–NEW and
title ‘‘Information Request Regarding pH
of Smokeless Tobacco Products.’’ Also
include the FDA docket number found
in brackets in the heading of this
document.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
VerDate Sep<11>2014
16:21 Oct 28, 2014
Jkt 235001
Information Request Regarding pH of
Smokeless Tobacco Products—(OMB
Control Number 0910–NEW)
On June 22, 2009, President Obama
signed the Family Smoking Prevention
and Tobacco Control Act (the Tobacco
Control Act) (Pub. L. 111–31) into law.
The Tobacco Control Act amended the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) by granting FDA
authority to regulate the manufacture,
marketing, and distribution of tobacco
products to protect the public health
generally and to reduce tobacco use by
minors.
Section 904(b) of the FD&C Act (21
U.S.C. 387d(b)) states that at the request
of the Secretary, each tobacco product
manufacturer or importer, or agents
thereof, must submit:
• Any or all documents (including
underlying scientific information)
relating to research activities, and
research findings, conducted,
supported, or possessed by the
manufacturer (or agents thereof) on the
health, toxicological, behavioral, or
physiological effects of tobacco products
and their constituents (including smoke
constituents), ingredients, components,
and additives.
• Any or all documents (including
underlying scientific or financial
information) relating to research
activities, and research findings,
conducted, supported, or possessed by
the manufacturer (or agents thereof) that
relate to the issue of whether a
reduction in risk to health from tobacco
products can occur upon the
employment of technology available or
known to the manufacturer.
• Any or all documents (including
underlying scientific or financial
information) relating to marketing
research involving the use of tobacco
products or marketing practices and the
effectiveness of such practices used by
tobacco manufacturers and distributors.
If the Secretary requests information
from the manufacturer of a tobacco
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
product not manufactured in the United
States, the importer of the tobacco
product is required to supply the
information. FDA is requesting OMB
approval of an information collection
under section 904(b) of the FD&C Act.
To become better informed about the
impact of the use of tobacco products on
the public health, FDA would request
information about the effects of product
pH in smokeless tobacco products from
all tobacco product manufacturers. FDA
would send letters to tobacco product
manufacturers and importers who FDA
has identified as having an obligation to
respond based on information before the
Agency. The requested information
would include information about
research requested under section 904(b)
of the FD&C Act as well as information
to be provided voluntarily beyond the
inquiries described in section 904(b).
I. Information Requested
The proposed request would include
the following information:
All documents (including underlying
scientific information and financial
information) relating to research
activities and research findings
conducted, supported, or possessed by
the respondent or the respondent’s
agents relating to a specified set of
topics listed in this document. The
request includes but is not limited to
documents relating to research findings
and activities, if any, that the
respondent possesses as the result of
acquiring or merging with another
company. For purposes of the request,
‘‘research’’ would include, but would
not be limited to, focus groups, surveys,
experimental clinical studies,
toxicological and biochemical assays, in
vivo and in vitro assays including
animal testing, laboratory formulation
and processing testing, taste panels, and
assessments of the effectiveness of
product marketing practices. The
request would apply to research relating
to any and all smokeless tobacco
products, including but not limited to
those products for research,
investigational use, developmental
studies, test marketing, and/or
commercial marketing, and also to the
E:\FR\FM\29OCN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 209 (Wednesday, October 29, 2014)]
[Notices]
[Pages 64392-64394]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-25637]
-----------------------------------------------------------------------
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
November 28, 2014.
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 0910-0308.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@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 (PHS) 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.\1\
---------------------------------------------------------------------------
\1\ Please note that throughout the regulations referenced in
relation to these information collections, licensed biological
products refers to biologics licensed under any provision of section
351 of the PHS Act.
---------------------------------------------------------------------------
The primary purpose of FDA's AER system is to identify potentially
serious safety problems with licensed biological products. Although the
premarket approval process is meant to disclose 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 AERS 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 follow-up 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 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
[[Page 64393]]
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) 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. The recordkeeping requirements for Sec. Sec. 610.12(g),
610.13(a)(2), 610.18(d), 680.2(f) and 680.3(f) are approved under OMB
control number 0910-0139.
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. In table 1, 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) 2013. Based on
information obtained from FDA's database system, there were 131
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 2013. There were an estimated 92,470
15-day Alert reports, 132,667 periodic reports, and 334 lot
distribution reports submitted to FDA. The number of 15-day Alert
reports for postmarketing studies under Sec. 600.80(e) is included in
the total number of 15-day Alert reports. FDA received 64 requests from
35 manufacturers for waivers under Sec. 600.90, of which 63 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 7, 2014 (79 FR 19097), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment; however, this
comment did not address the information collection.
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)...... 131 705.88 92,470 1 92,470
600.80(c)(2).................... 131 1,012.73 132,667 28 3,714,676
600.81.......................... 131 2.55 334 1 334
600.90.......................... 35 1.83 64 1 64
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 3,807,544
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
In table 2, 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 334 licensed
manufacturers of biological products in FY 2013. However, the number of
recordkeepers listed for Sec. 600.12(a) through (e) excluding (b)(2)
is estimated to be 164. 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
2013 (6,887), number of recalls made (1,679), and total number of
adverse experience reports received (225,137) in FY 2013. The hours per
record are based on FDA experience.
FDA estimates the burden of this recordkeeping as follows:
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
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600.12 \2\...................... 164 41.99 6,887 32 220,384
600.12(b)(2).................... 334 5.03 1,679 24 40,296
[[Page 64394]]
600.80(c)(1) and 600.80(i)...... 131 1,718.60 225,137 1 225,137
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Total....................... .............. .............. .............. .............. 485,817
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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: October 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25637 Filed 10-28-14; 8:45 am]
BILLING CODE 4164-01-P
