Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records, 28486-28488 [E8-11057]
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28486
Federal Register / Vol. 73, No. 96 / Friday, May 16, 2008 / Notices
in the next 3 years. However, to avoid
counting this burden as zero, FDA has
estimated the burden at one respondent
making one submission a year for a total
of one annual submission.
The hours per response values were
estimated as follows: First, we assumed
that the information requested in the
guidance is readily available to the
submitter. We expect that the submitter
will need to gather information from
appropriate persons in the submitter’s
company and to prepare this
information for submission to FDA. The
submitter will almost always merely
need to copy existing documentation.
We believe that this effort should take
no longer than 3 hours per submission.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
Activity
Develop documentation process
1There
Annual Frequency
per Recordkeeping
1
Total Annual
Records
1
1
Total Hours
16
16
are no capital costs or operating and maintenance costs associated with this collection of information.
In determining the estimated annual
recordkeeping burden, FDA estimated
that at least 90 percent of firms maintain
documentation, such as packing codes,
batch records, and inventory records, as
part of their basic food production or
import operations. Therefore, the
recordkeeping burden was calculated as
the time required for the 10 percent of
firms that may not be currently
maintaining this documentation to
develop and maintain documentation,
such as batch records and inventory
records. In previous information
collection requests, this recordkeeping
burden was estimated to be 16 hours per
record. FDA has retrained its prior
estimate of 16 hours per record for the
recordkeeping burden. As shown in
table 1 of this document, FDA estimates
that one respondent will make one
submission per year. Although FDA
estimates that only 1 out of 10 firms will
not be currently maintaining the
necessary documentation, to avoid
counting the recordkeeping burden for
the 1 submission per year as 1/10 of a
recordkeeper, FDA estimates that 1
recordkeeper will take 16 hours to
develop and maintain documentation
recommended by the guidance.
Dated: May 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–10985 Filed 5–15–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
collection of information to OMB for
review and clearance.
Food and Drug Administration
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 which 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 licensed manufacturers to
report each adverse experience that is
both serious and unexpected, whether
[Docket No. FDA–2008–N–0073]
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 June 16,
2008.
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:
202–395–6974, or e-mailed to
baguilar@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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
sroberts on PROD1PC70 with NOTICES
Hours per
Record
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
16:18 May 15, 2008
Jkt 214001
PO 00000
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Fmt 4703
Sfmt 4703
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16MYN1
28487
Federal Register / Vol. 73, No. 96 / Friday, May 16, 2008 / Notices
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 are
known as postmarketing 15-day Alert
reports. Section 600.80(c)(1) also
requires licensed manufacturers to
submit any followup reports within 15calendar 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 for an adverse experience
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 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 will be submitted annually
because 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
semiannual distribution reports provide
FDA with important information about
products distributed under biologics
licenses, including the quantity, certain
lot numbers, labeled date of expiration,
number of dosage units, and date of
release. Under § 600.90, a licensed
manufacturer may submit a waiver
request for any requirements that
applies 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, concurrently with the
performance of each step 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, manufacturers must
maintain records of sterilization of
equipment and supplies, animal
necropsy records, and records in cases
of divided manufacturing of a product.
Section 600.12(b)(2) requires
manufacturers to maintain complete
records pertaining to the recall from
distribution of any product.
Respondents to this collection of
information are manufacturers of
biological products. Under table 1 of
this document, the number of
respondents is based on the estimated
number of manufacturers that submitted
the required information to the Center
for Biologics Evaluation and Research
and Center for Drug Evaluation and
Research, FDA, in fiscal year (FY) 2006.
Based on information obtained from
FDA’s database system, there were 88
licensed biologics manufacturers. This
number excludes those manufacturers
who produce blood and blood
components and in-vitro diagnostic
licensed products, because § 600.80(k)
specifically exempts manufacturers of
these products from adverse experience
reporting requirements. The total annual
responses are based on the estimated
number of submissions received
annually by FDA in FY 2006. However,
not all manufacturers have submissions
in a given year and some may have
multiple submissions. There were an
estimated 23,835 15-day Alert reports,
21,872 periodic reports, and 179 lot
distribution reports submitted to FDA.
The number of 15-day Alert reports for
postmarketing studies under § 600.80(e)
is included in the total number of 15day Alert reports. FDA received 6
requests for waiver under § 600.90, all of
which 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 no. 0910–0291.
In the Federal Register of February
15, 2008 (73 FR 8881), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
600.80(c)(1) and 600.80(e)
88
270.85
23,835
1
23,835
600.80(c)(2)
88
248.55
21,872
28
612,416
600.81
88
2.03
179
1
179
600.90
6
6
1
6
1
Total
sroberts on PROD1PC70 with NOTICES
1 There
636,436
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 303 licensed manufacturers
of biological products in FY 2006.
However, the number of recordkeepers
VerDate Aug<31>2005
16:18 May 15, 2008
Jkt 214001
listed for § 600.12(a) through (e)
excluding (b)(2) is estimated to be 112.
This number excludes manufacturers of
blood and blood components because
their burden hours for recordkeeping
have been reported under 21 CFR
606.160 in OMB control no. 0910–0116.
The total annual records is based on the
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
annual average of lots released (5,291),
number of recalls made (1,841), and
total number of adverse experience
reports received (45,707) in FY 2006.
The hours per record are based on FDA
experience.
FDA estimates the burden of this
recordkeeping as follows:
E:\FR\FM\16MYN1.SGM
16MYN1
28488
Federal Register / Vol. 73, No. 96 / Friday, May 16, 2008 / Notices
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. Of
Recordkeepers
21 CFR Section
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
600.12
112
47.24
5,291
32
169,312
600.12(b)(2)
303
6.08
1,841
24
44,184
88
519.40
45,707
1
45,707
600.80(i)
Total
1 There
259,203
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 13, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–11057 Filed 5–15–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Dental &
Craniofacial Research; Notice of
Closed Meeting
sroberts on PROD1PC70 with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
Board of Scientific Counselors, National
Institute of Dental and Craniofacial
Research.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Institute of Dental &
Craniofacial Research, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, National Institute of Dental and
Craniofacial Research.
Date: June 9–11, 2008.
Time: June 9, 2008, 7 p.m. to 9 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
Building 30, 30 Convent Drive, Room 117,
Bethesda, MD 20892.
Time: June 10, 2008, 8 a.m. to 8 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
Building 30, 30 Convent Drive, Room 117,
Bethesda, MD 20892.
VerDate Aug<31>2005
16:18 May 15, 2008
Jkt 214001
Time: June 11, 2008, 8 a.m. to 12:30 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
Building 30, 30 Convent Drive, Room 117,
Bethesda, MD 20892.
Contact Person: Norman S Braveman,
Assistant to the Director, NIH—NIDCR, 31
Center Drive, Bldg. 31, Room 5B55, Bethesda,
MD 20892, 301 594–2089,
norman.braveman@nih.gov.
Information is also available on the
Institute’s/Center’s home page: https://
www.nidcr.nih.gov/about/
CouncilCommittees.asp, where an agenda
and any additional information for the
meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.121, Oral Diseases and
Disorders Research, National Institutes of
Health, HHS)
Dated: May 8, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–10836 Filed 5–15–08; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Frm 00065
Fmt 4703
Sfmt 4703
Dated: May 8, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–10837 Filed 5–15–08; 8:45 am]
BILLING CODE 4140–01–M
Center for Scientific Review; Notice of
Closed Meeting
PO 00000
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Inner Ear Hair Cells.
Date: May 22, 2008.
Time: 1 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Daniel R. Kenshalo, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5176,
MSC 7844, Bethesda, MD 20892, 301–435–
1255, kenshalod@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Pathobiology of
Kidney Disease Study Section, June 12,
2008, 8 a.m. to June 13, 2008, 5 p.m.,
Hotel Deca, 4507 Brooklyn Avenue, NE.,
Seattle, WA 98105 which was published
in the Federal Register on May 2, 2008,
73 FR 24296–24298.
The meeting will be held one day
only June 12, 2008. The meeting time
and location remain the same. The
meeting is closed to the public.
E:\FR\FM\16MYN1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 96 (Friday, May 16, 2008)]
[Notices]
[Pages 28486-28488]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-11057]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0073]
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 June
16, 2008.
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: 202-395-6974, or e-mailed to baguilar@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: Jonna Capezzuto, Office of the Chief
Information Officer (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
which 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 licensed
manufacturers to report each adverse experience that is both serious
and unexpected, whether
[[Page 28487]]
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 are known as postmarketing 15-day Alert reports.
Section 600.80(c)(1) also requires licensed manufacturers 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 for an adverse experience 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 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 will
be submitted annually because 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 semiannual
distribution reports provide FDA with important information about
products distributed under biologics licenses, including the quantity,
certain lot numbers, labeled date of expiration, number of dosage
units, and date of release. Under Sec. 600.90, a licensed manufacturer
may submit a waiver request for any requirements that applies to the
licensed manufacturer under 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, concurrently with the
performance of each step 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, manufacturers
must maintain records of sterilization of equipment and supplies,
animal necropsy records, and records in cases of divided manufacturing
of a product. Section 600.12(b)(2) requires manufacturers to maintain
complete records pertaining to the recall from distribution of any
product.
Respondents to this collection of information are manufacturers of
biological products. Under table 1 of this document, the number of
respondents is based on the estimated number of manufacturers that
submitted the required information to the Center for Biologics
Evaluation and Research and Center for Drug Evaluation and Research,
FDA, in fiscal year (FY) 2006. Based on information obtained from FDA's
database system, there were 88 licensed biologics manufacturers. This
number excludes those manufacturers who produce blood and blood
components and in-vitro diagnostic licensed products, because Sec.
600.80(k) specifically exempts manufacturers of these products from
adverse experience reporting requirements. The total annual responses
are based on the estimated number of submissions received annually by
FDA in FY 2006. However, not all manufacturers have submissions in a
given year and some may have multiple submissions. There were an
estimated 23,835 15-day Alert reports, 21,872 periodic reports, and 179
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 6 requests for
waiver under Sec. 600.90, all of which 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 no. 0910-0291.
In the Federal Register of February 15, 2008 (73 FR 8881), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
600.80(c)(1) 88 270.85 23,835 1 23,835
and 600.80(e)
----------------------------------------------------------------------------------------------------------------
600.80(c)(2) 88 248.55 21,872 28 612,416
----------------------------------------------------------------------------------------------------------------
600.81 88 2.03 179 1 179
----------------------------------------------------------------------------------------------------------------
600.90 6 1 6 1 6
----------------------------------------------------------------------------------------------------------------
Total 636,436
----------------------------------------------------------------------------------------------------------------
\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 303
licensed manufacturers of biological products in FY 2006. However, the
number of recordkeepers listed for Sec. 600.12(a) through (e)
excluding (b)(2) is estimated to be 112. This number excludes
manufacturers of blood and blood components because their burden hours
for recordkeeping have been reported under 21 CFR 606.160 in OMB
control no. 0910-0116. The total annual records is based on the annual
average of lots released (5,291), number of recalls made (1,841), and
total number of adverse experience reports received (45,707) in FY
2006. The hours per record are based on FDA experience.
FDA estimates the burden of this recordkeeping as follows:
[[Page 28488]]
Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
No. Of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
----------------------------------------------------------------------------------------------------------------
600.12 112 47.24 5,291 32 169,312
----------------------------------------------------------------------------------------------------------------
600.12(b)(2) 303 6.08 1,841 24 44,184
----------------------------------------------------------------------------------------------------------------
600.80(i) 88 519.40 45,707 1 45,707
----------------------------------------------------------------------------------------------------------------
Total 259,203
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: May 13, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-11057 Filed 5-15-08; 8:45 am]
BILLING CODE 4160-01-S
