Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records, 20571-20573 [05-7824]
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20571
Federal Register / Vol. 70, No. 75 / Wednesday, April 20, 2005 / Notices
must submit to FDA a Notice of Claimed
Investigational Exemption (INAD),
before shipping the new animal drug for
clinical tests in animals. The INAD must
contain, among other things, the
following specific information: (1)
Identity of the new animal drug, (2)
labeling, (3) statement of compliance of
any nonclinical laboratory studies with
good laboratory practices, (4) name and
address of each clinical investigator, (5)
the approximate number of animals to
be treated or amount of new animal
drug(s) to be shipped, and (6)
information regarding the use of edible
tissues from investigational animals.
Part 511 also requires that records be
established and maintained to
document the distribution and use of
the investigational drug to assure that its
use is safe, and that distribution is
controlled to prevent potential abuse.
The agency utilizes these required
records under its Bio-Research
Monitoring Program to monitor the
validity of the studies submitted to FDA
to support new animal drug approval
and to assure that proper use of the drug
is maintained by the investigator.
Investigational new animal drugs are
used primarily by drug industry firms,
academic institutions, and the
government. Investigators may include
individuals from these entities as well
as research firms and members of the
medical profession. Respondents to this
collection of information are the persons
who use new animal drugs
investigationally.
In the Federal Register of November
10, 2004 (69 FR 65198), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden for this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
511.1(b)(4)
190
4.09
778
8
6,224
511.1(b)(5)
190
0.58
110
140
15,400
511.1(b)(6)
190
.01
20
1
20
511.1(b)(8)(ii)
190
.005
1
20
20
511.1(b)(9)
190
.10
20
8
160
Total
1 There
21,824
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
Annual Frequency
per Record
Total Annual
Records
Hours per
Recordkeeper
Total Hours
511.1(a)(3)
190
2.11
400
9
3,600
511.1(b)(3)
190
4.20
798
1
798
511.1(b)(7)(ii)
400
3.00
1,200
3.5
4,200
511.1(b)(8)(i)
190
6.38
1,200
3.5
4,200
Total
1 There
12,798
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of the time required for
reporting requirements, record
preparation and maintenance for this
collection of information is based on
agency communication with industry.
Additional information needed to make
a final calculation of the total burden
hours (i.e. the number of respondents,
the number of recordkeepers, the
number of INAD applications received,
etc.) is derived from agency records.
Dated: April 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–7823 Filed 4–19–05; 8:45 am]
16:34 Apr 19, 2005
Food and Drug Administration
[Docket No. 2004N–0469]
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:
Jkt 205001
Food and Drug Administration,
HHS.
ACTION:
BILLING CODE 4160–01–S
VerDate jul<14>2003
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
Notice.
Frm 00057
Fmt 4703
Sfmt 4703
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 May 20,
2005.
OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
the information collection are received,
OMB recommends that written
ADDRESSES:
E:\FR\FM\20APN1.SGM
20APN1
20572
Federal Register / Vol. 70, No. 75 / Wednesday, April 20, 2005 / Notices
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
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—(OMB Control
Number 0910–0308—Extension)
Under the Public Health Service Act
(42 U.S.C. 262), FDA is required to
ensure the marketing of only those
biological products that are safe and
effective. FDA must, therefore, be
informed of all adverse experiences
occasioned by the use of licensed
biological products. 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 flag
potentially serious safety problems with
licensed biological products, focusing
especially on newly licensed 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.
Reports are obtained from a variety of
sources, including patients, physicians,
foreign regulatory agencies, and clinical
investigators. Information derived from
the AER system contributes directly to
increased public health protection
because such information enables FDA
to recommend important changes to the
product’s labeling (such as adding a
new warning), to initiate removal of a
biological product from the market
when necessary, and to assure the
manufacturer has taken adequate
corrective action, if necessary.
The regulation in § 600.80(c)(1)
requires the licensed manufacturer to
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16:34 Apr 19, 2005
Jkt 205001
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 and to
submit any followup reports within 15
calendar days of receipt of new
information, or as requested by FDA.
Section 600.80(e) requires licensed
manufacturers to submit a 15-day alert
report obtained from a postmarketing
clinical study only if there is a
reasonable possibility that the product
caused the adverse experience. Section
600.80(c)(2) requires the licensed
manufacturer to report each adverse
experience not reported under
§ 600.80(c)(1)(i) at quarterly intervals,
for 3 years from the date of issuance of
the biologics license, and then at annual
intervals. The majority of the periodic
reports will be submitted annually since
a large percentage of the current
licensed biological products have been
licensed longer than 3 years. Section
600.80(i) requires the licensed
manufacturer 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 the licensed manufacturer to
submit information about the quantity
of the product distributed under the
biologics license, including the quantity
distributed to distributors at an interval
of every 6 months. The semiannual
distribution report informs FDA of the
quantity, certain lot numbers, labeled
date of expiration, the number of doses,
and date of release. Under § 600.90, a
licensed manufacturer may submit a
waiver request that applies to the
licensed manufacturer under § § 600.80
and 600.81. A waiver request submitted
under § 600.90 must be submitted with
supporting documentation.
Manufacturers of biological products
for human use must keep records of
each step in the manufacture and
distribution of products including the
recalls of the product. The
recordkeeping requirements serve
preventative and remedial purposes.
These requirements establish
accountability and traceability in the
manufacture and distribution of
products, and enable FDA to perform
meaningful inspections.
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Section 600.12 requires that all
records of each step in the manufacture
and distribution of a product be made
and 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, records of sterilization
of equipment and supplies, animal
necropsy records, and records in cases
of divided manufacturing of a product
are required to be maintained. Section
600.12(b)(2) requires complete records
to be maintained pertaining to the recall
from distribution of any product.
Respondents to this collection of
information are manufacturers of
biological products. In table 1 of this
document, the number of respondents is
based on the estimated number of
manufacturers that submitted the
required information to FDA in fiscal
year (FY) 2002 and 2003. Based on
information obtained from the Center
for Biologics Evaluation and Research’s
(CBER’s) database system, there were 90
licensed biologics manufacturers. This
number excludes those manufacturers
who produce blood and blood
components and in-vitro diagnostic
licensed products because these
products are specifically exempt from
the regulations under § 600.80(k). The
total annual responses are based on the
average estimated number of
submissions received annually by FDA
for FY 2002 and 2003. However, not all
manufacturers have submissions in a
given year and some may have multiple
submissions. There were an estimated
15,126 15-day alert reports, 6,550
periodic reports, and 323 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 an
average of five waiver requests for FY
2002 and 2003 under § 600.90, all of
which were approved for exemption of
the AER requirements. The hours per
response are based on FDA’s
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 November
3, 2004 (69 FR 64069), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
E:\FR\FM\20APN1.SGM
20APN1
20573
Federal Register / Vol. 70, No. 75 / Wednesday, April 20, 2005 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Respondent
Total Hours
600.80(c)(1) and (e)
90
168.07
15,126
1
15,126
600.80(c)(2)
90
72.78
6,550
28
183,400
600.81
90
3.59
323
1
355
600.90
5
1
5
1
5
Total
198,886
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
Annual Frequency
per Record
Total Annual
Records
Hours per
Recordkeeper
Total Hours
600.12
116
57.16
6,630
32
212,160
600.12(b)(2)
320
6.12
1,958
24
46,992
90
394.27
35,484
1
35,484
600.80(i)
Total
294,636
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–7824 Filed 4–19–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0123]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Survey of Need for
Online Medical Device Information
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 and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
a survey of customers who should be
served by FDA’s Center for Devices and
Radiological Health (CDRH) Web site, in
VerDate jul<14>2003
16:34 Apr 19, 2005
Jkt 205001
order to determine the kind and quality
of services they want.
DATES: Submit written or electronic
comments on the collection of
information by June 20, 2005.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
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 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
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
the Federal Register concerning each
proposed 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.
Survey of Need for Online Medical
Device Information
Executive Order 12862 directs
agencies to identify the customers who
are, or should be, served by the agency,
and to survey customers to determine
the kind and quality of services they
want.
This proposed survey will collect data
about the information customers want
E:\FR\FM\20APN1.SGM
20APN1
]]>Agencies
[Federal Register Volume 70, Number 75 (Wednesday, April 20, 2005)]
[Notices]
[Pages 20571-20573]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7824]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0469]
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 May 20,
2005.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that written
[[Page 20572]]
comments be faxed to the Office of Information and Regulatory Affairs,
OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4659.
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--(OMB Control Number 0910-0308--Extension)
Under the Public Health Service Act (42 U.S.C. 262), FDA is
required to ensure the marketing of only those biological products that
are safe and effective. FDA must, therefore, be informed of all adverse
experiences occasioned by the use of licensed biological products. 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 flag potentially serious safety
problems with licensed biological products, focusing especially on
newly licensed 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. Reports are
obtained from a variety of sources, including patients, physicians,
foreign regulatory agencies, and clinical investigators. Information
derived from the AER system contributes directly to increased public
health protection because such information enables FDA to recommend
important changes to the product's labeling (such as adding a new
warning), to initiate removal of a biological product from the market
when necessary, and to assure the manufacturer has taken adequate
corrective action, if necessary.
The regulation in Sec. 600.80(c)(1) requires the licensed
manufacturer 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 and to submit any followup reports within
15 calendar days of receipt of new information, or as requested by FDA.
Section 600.80(e) requires licensed manufacturers to submit a 15-
day alert report obtained from a postmarketing clinical study only if
there is a reasonable possibility that the product caused the adverse
experience. Section 600.80(c)(2) requires the licensed manufacturer to
report each adverse experience not reported under Sec. 600.80(c)(1)(i)
at quarterly intervals, for 3 years from the date of issuance of the
biologics license, and then at annual intervals. The majority of the
periodic reports will be submitted annually since a large percentage of
the current licensed biological products have been licensed longer than
3 years. Section 600.80(i) requires the licensed manufacturer 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 the licensed manufacturer to submit information about the
quantity of the product distributed under the biologics license,
including the quantity distributed to distributors at an interval of
every 6 months. The semiannual distribution report informs FDA of the
quantity, certain lot numbers, labeled date of expiration, the number
of doses, and date of release. Under Sec. 600.90, a licensed
manufacturer may submit a waiver request that applies to the licensed
manufacturer under Sec. Sec. 600.80 and 600.81. A waiver request
submitted under Sec. 600.90 must be submitted with supporting
documentation.
Manufacturers of biological products for human use must keep
records of each step in the manufacture and distribution of products
including the recalls of the product. The recordkeeping requirements
serve preventative and remedial purposes. These requirements establish
accountability and traceability in the manufacture and distribution of
products, and enable FDA to perform meaningful inspections.
Section 600.12 requires that all records of each step in the
manufacture and distribution of a product be made and 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, records of
sterilization of equipment and supplies, animal necropsy records, and
records in cases of divided manufacturing of a product are required to
be maintained. Section 600.12(b)(2) requires complete records to be
maintained pertaining to the recall from distribution of any product.
Respondents to this collection of information are manufacturers of
biological products. In table 1 of this document, the number of
respondents is based on the estimated number of manufacturers that
submitted the required information to FDA in fiscal year (FY) 2002 and
2003. Based on information obtained from the Center for Biologics
Evaluation and Research's (CBER's) database system, there were 90
licensed biologics manufacturers. This number excludes those
manufacturers who produce blood and blood components and in-vitro
diagnostic licensed products because these products are specifically
exempt from the regulations under Sec. 600.80(k). The total annual
responses are based on the average estimated number of submissions
received annually by FDA for FY 2002 and 2003. However, not all
manufacturers have submissions in a given year and some may have
multiple submissions. There were an estimated 15,126 15-day alert
reports, 6,550 periodic reports, and 323 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 an average of five waiver requests for FY
2002 and 2003 under Sec. 600.90, all of which were approved for
exemption of the AER requirements. The hours per response are based on
FDA's 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 November 3, 2004 (69 FR 64069), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
[[Page 20573]]
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Respondent Total Hours
----------------------------------------------------------------------------------------------------------------
600.80(c)(1) and 90 168.07 15,126 1 15,126
(e)
----------------------------------------------------------------------------------------------------------------
600.80(c)(2) 90 72.78 6,550 28 183,400
----------------------------------------------------------------------------------------------------------------
600.81 90 3.59 323 1 355
----------------------------------------------------------------------------------------------------------------
600.90 5 1 5 1 5
----------------------------------------------------------------------------------------------------------------
Total 198,886
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers per Record Records Recordkeeper Total Hours
----------------------------------------------------------------------------------------------------------------
600.12 116 57.16 6,630 32 212,160
----------------------------------------------------------------------------------------------------------------
600.12(b)(2) 320 6.12 1,958 24 46,992
----------------------------------------------------------------------------------------------------------------
600.80(i) 90 394.27 35,484 1 35,484
----------------------------------------------------------------------------------------------------------------
Total 294,636
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7824 Filed 4-19-05; 8:45 am]
BILLING CODE 4160-01-S
