Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies, 36531-36533 [E8-14535]
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Federal Register / Vol. 73, No. 125 / Friday, June 27, 2008 / Notices
DFO by 5 p.m. (e.d.t.), Monday, August
4, 2008, for consideration.
The number of oral presentations may
be limited by the time available. Oral
presentations should not exceed 5
minutes in length for an individual or
an organization.
The Chair may further limit time
allowed for presentations due to the
number of oral presentations, if
necessary.
V. Presenter and Presentation
Information
All presenters must submit Form
CMS–20017 (revised 01/07). Hardcopies
are required for oral presentations;
however, electronic submissions of
Form CMS–20017 are optional. The
DFO must receive the following
information from those wishing to make
oral presentations:
• Form CMS–20017 completed with
all pertinent information identified on
the first page of the presentation.
• One hardcopy of presentation.
• Electronic copy of presentation.
• Personal registration information as
described in the Meeting Attendance
section below.
• Those persons wishing to submit
comments only must send hardcopy and
electronic versions of their comments,
but they are not required to submit
Form CMS–20017.
jlentini on PROD1PC65 with NOTICES
VI. Oral Comments
In addition to formal oral
presentations, there will be opportunity
during the meeting for public oral
comments, which will be limited to 1
minute for each individual and a total
of 3 minutes per organization.
VII. Meeting Attendance
The meeting is open to the public;
however, attendance is limited to space
available. Attendance will be
determined on a first-come, first-served
basis.
Persons wishing to attend this
meeting, which is located on Federal
property, must e-mail the DFO to
register in advance no later than 5 p.m.
(e.d.t.), Wednesday, August 13, 2008. A
confirmation will be sent to the
requester(s) by return e-mail.
The following personal information
must be e-mailed to the DFO by the date
and time above:
• Name(s) of attendee(s);
• Title(s);
• Organization;
• E-mail address(es); and
• Telephone number(s).
VIII. Security, Building, and Parking
Guidelines
Because this meeting will be located
on Federal property, for security
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reasons, any persons wishing to attend
this meeting must register by close of
business on Wednesday, August 13,
2008. Individuals who have not
registered in advance will not be
allowed to enter the building to attend
the meeting. Seating capacity is limited
to the first 250 registrants.
The on-site check-in for visitors will
be held 30 to 45 minutes before the
meeting start time each day. You should
allow sufficient time to go through the
security checkpoints. It is suggested that
you arrive at 7500 Security Boulevard
no later than 12:15 p.m. for the 1 p.m.
meeting on Wednesday, August 27,
2008. Plan to arrive at the building by
7:15 a.m. on Thursday, August 28, 2008
(and Friday, August 29, 2008—if we
have a meeting that day) to ensure that
you are able to arrive promptly at the
meeting by 8 a.m. All items brought to
the building, whether personal or for the
purpose of demonstration or to support
a presentation, are subject to inspection.
Security measures will include
inspection of vehicles, inside and out, at
the entrance to the grounds. In addition,
all persons entering the building must
pass through a metal detector. All items
brought to CMS, including personal
items such as desktops, cell phones, and
palm pilots, are subject to physical
inspection.
The following are the security,
building, and parking guidelines:
• Persons attending the meeting
including presenters must be registered
and on the attendance list by the
prescribed date.
• Individuals who are not registered
in advance will not be permitted to
enter the building and will be unable to
attend the meeting.
• Attendees must present
photographic identification to the
Federal Protective Service or Guard
Service personnel before entering the
building.
• Security measures include
inspection of vehicles, inside and out, at
the entrance to the grounds.
• The main-entrance guards will
issue parking permits and instructions
upon arrival at the building.
• The public may enter the building
30 to 45 minutes before the meeting
convenes each day.
• All visitors must be escorted in
areas other than the lower and first-floor
levels in the Central Building.
IX. Special Accommodations
Individuals requiring sign-language
interpretation or other special
accommodations must send a request
for these services to the DFO by 5 p.m.
(e.d.t.), Wednesday, August 13, 2008.
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36531
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: May 16, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. E8–13828 Filed 6–26–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0154]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Good Laboratory
Practice Regulations for Nonclinical
Studies
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.
Fax written comments on the
collection of information by July 28,
2008.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0119. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1482.
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:
E:\FR\FM\27JNN1.SGM
27JNN1
36532
Federal Register / Vol. 73, No. 125 / Friday, June 27, 2008 / Notices
Good Laboratory Practice (GLP)
Regulations for Nonclinical Studies—21
CFR Part 58 (OMB Control Number
0910–0119)—Extension
Sections 409, 505, 512, and 515 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 348, 355, 360(b), 360(e)) and
related statues require manufacturers of
food additives, human drugs and
biological products, animal drugs, and
medical devices to demonstrate the
safety and utility of their product by
submitting applications to FDA for
research or marketing permits. Such
applications contain, among other
important items, full reports of all
studies done to demonstrate product
safety in man and/or other animals. In
order to ensure adequate quality control
for these studies and to provide an
adequate degree of consumer protection,
the agency issued the GLP regulations.
The regulations specify minimum
standards for the proper conduct of
safety testing and contain sections on
facilities, personnel, equipment,
standard operating procedures (SOPs),
test and control articles, quality
assurance, protocol and conduct of a
safety study, records and reports, and
laboratory disqualification.
The GLP regulations contain
requirements for the reporting of the
results of quality assurance unit
inspections, test and control article
characterization, testing of mixtures of
test and control articles with carriers,
and an overall interpretation of
nonclinical laboratory studies. The GLP
regulations also contain recordkeeping
requirements relating to the conduct of
safety studies. Such records include the
following information: (1) Personnel job
descriptions and summaries of training
and experience; (2) master schedules,
protocols and amendments thereto,
inspection reports, and SOPs; (3)
equipment inspection, maintenance,
calibration, and testing records; (4)
documentation of feed and water
analyses and animal treatments; (5) test
article accountability records; and (6)
study documentation and raw data.
The information collected under GLP
regulations is generally gathered by
testing facilities routinely engaged in
conducting toxicological studies and is
used as part of an application for a
research or marketing permit that is
voluntarily submitted to FDA by
persons desiring to market new
products. The facilities that collect this
information are typically operated by
large entities, e.g., contract laboratories,
sponsors of FDA-regulated products,
universities, or Government agencies.
Failure to include the information in a
filing to FDA would mean that agency
scientific experts could not make a valid
determination of product safety. FDA
receives, reviews, and approves
hundreds of new product applications
each year based on information
received. The recordkeeping
requirements are necessary to document
the proper conduct of a safety study, to
assure the quality and integrity of the
resulting final report, and to provide
adequate proof of the safety of regulated
products. FDA conducts onsite audits of
records and reports, during its
inspections of testing laboratories, to
verify reliability of results submitted in
applications.
The likely respondents collecting this
information are contract laboratories,
sponsors of FDA-regulated products,
universities, or Government agencies.
In the Federal Register of March 12,
2008 (73 FR 13240), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
58.35(b)(7)
300
60.25
18,075
1
18,075
58.185
300
60.25
18,075
27.65
499,774
Total
1There
517,849
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 Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
300
20
6,000
.21
1,260
58.35(b)(1) through (b)(6) and (c)
300
270.76
81,228
3.36
272,926
58.63(b) and (c)
300
60
18,000
.09
1,620
58.81(a) through (c)
300
301.8
90,540
.14
12,676
58.90(c) and (g)
300
62.7
18,810
.13
2,445
58.105(a) and (b)
300
5
1,500
11.8
17,700
58.107(d)
300
1
300
4.25
1,275
58.113(a)
jlentini on PROD1PC65 with NOTICES
58.29(b)
300
15.33
4,599
6.8
31,273
58.120
300
15.38
4,614
32.7
150,878
58.195
300
251.5
75,450
3.9
294,255
Total
1There
786,308
are no capital costs or operating and maintenance costs associated with this collection of information.
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PO 00000
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E:\FR\FM\27JNN1.SGM
27JNN1
36533
Federal Register / Vol. 73, No. 125 / Friday, June 27, 2008 / Notices
Dated: June 20, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–14535 Filed 6–26–08; 8:45 am]
BILLING CODE 4160–01–S
Food and Drug Administration
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:
[Docket No. FDA–2008–N–0172]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; New Animal Drugs
for Investigational Use
Food and Drug Administration,
HHS.
ACTION:
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
control number 0910–0117. Also
include the FDA docket number found
in brackets in the heading of this
document.
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 July 28,
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
New Animal Drugs for Investigational
Use (OMB Control Number 0910–
0117)—Extension
FDA has authority under the Federal
Food, Drug, and Cosmetic Act (the act)
to approve new animal drugs. Section
512(j) of the act (21 U.S.C.360b(j)),
authorized FDA to issue regulations for
the investigational use of new animal
drugs. The regulations which set forth
conditions for investigational use of
new animal drugs are codified under
part 511 (21 CFR part 511). If a new
animal drug is only for tests in vitro, or
testing in laboratory research animals,
the person distributing the new animal
drug must maintain records showing: (1)
The name and post office address of the
expert or expert organization to whom
the drug is shipped; and (2) the date,
quantity, batch or code mark for each
shipment for a period of 2 years after
such shipment or delivery. Prior to
shipping a new animal drug for clinical
investigations in animals, a sponsor
must submit to FDA a Notice of Claimed
Investigational Exemption (NCIE). The
NCIE must contain, among other things,
the following specific information: (1)
The identity of the new animal drug, (2)
labeling, (3) a statement of compliance
of any non-clinical laboratory studies
with good laboratory practices, (4) the
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 the distribution is
controlled to prevent potential abuse.
The agency uses 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 the pharmaceutical
industry, academic institutions, and the
government. Investigators may include
individuals from these entities as well
as research firms and members of the
medical professional. Respondents to
this collection of information are
investigators who use new animal drugs
for investigational purposes.
In the Federal Register of April 8,
2008 (73 FR 19073), 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
511.1(b)(4)
134
7.66
1027
8
8,216
511.1(b)(5)
134
.19
25
140
3,500
511.1(b)(6)
134
.01
2
1
2
511.1(b)(8) (ii)
134
.11
15
20
300
511.1(b)(9)
134
20
8
160
6.7
Total
1 There
12,178
are no capital costs or operating and maintenance costs associated with this collection of information.
jlentini on PROD1PC65 with NOTICES
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Recordkeeper
Total Hours
511.1(a)(3)
134
2.96
400
9
3,600
511.1(b)(3)
134
7.66
1,027
1
1,027
Sfmt 4703
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18:47 Jun 26, 2008
Jkt 214001
PO 00000
Frm 00043
Fmt 4703
27JNN1
]]>Agencies
[Federal Register Volume 73, Number 125 (Friday, June 27, 2008)]
[Notices]
[Pages 36531-36533]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-14535]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0154]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Good Laboratory
Practice Regulations for Nonclinical Studies
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 July
28, 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 0910-0119. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1482.
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.
[[Page 36532]]
Good Laboratory Practice (GLP) Regulations for Nonclinical Studies--21
CFR Part 58 (OMB Control Number 0910-0119)--Extension
Sections 409, 505, 512, and 515 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 348, 355, 360(b), 360(e)) and related statues
require manufacturers of food additives, human drugs and biological
products, animal drugs, and medical devices to demonstrate the safety
and utility of their product by submitting applications to FDA for
research or marketing permits. Such applications contain, among other
important items, full reports of all studies done to demonstrate
product safety in man and/or other animals. In order to ensure adequate
quality control for these studies and to provide an adequate degree of
consumer protection, the agency issued the GLP regulations. The
regulations specify minimum standards for the proper conduct of safety
testing and contain sections on facilities, personnel, equipment,
standard operating procedures (SOPs), test and control articles,
quality assurance, protocol and conduct of a safety study, records and
reports, and laboratory disqualification.
The GLP regulations contain requirements for the reporting of the
results of quality assurance unit inspections, test and control article
characterization, testing of mixtures of test and control articles with
carriers, and an overall interpretation of nonclinical laboratory
studies. The GLP regulations also contain recordkeeping requirements
relating to the conduct of safety studies. Such records include the
following information: (1) Personnel job descriptions and summaries of
training and experience; (2) master schedules, protocols and amendments
thereto, inspection reports, and SOPs; (3) equipment inspection,
maintenance, calibration, and testing records; (4) documentation of
feed and water analyses and animal treatments; (5) test article
accountability records; and (6) study documentation and raw data.
The information collected under GLP regulations is generally
gathered by testing facilities routinely engaged in conducting
toxicological studies and is used as part of an application for a
research or marketing permit that is voluntarily submitted to FDA by
persons desiring to market new products. The facilities that collect
this information are typically operated by large entities, e.g.,
contract laboratories, sponsors of FDA-regulated products,
universities, or Government agencies. Failure to include the
information in a filing to FDA would mean that agency scientific
experts could not make a valid determination of product safety. FDA
receives, reviews, and approves hundreds of new product applications
each year based on information received. The recordkeeping requirements
are necessary to document the proper conduct of a safety study, to
assure the quality and integrity of the resulting final report, and to
provide adequate proof of the safety of regulated products. FDA
conducts onsite audits of records and reports, during its inspections
of testing laboratories, to verify reliability of results submitted in
applications.
The likely respondents collecting this information are contract
laboratories, sponsors of FDA-regulated products, universities, or
Government agencies.
In the Federal Register of March 12, 2008 (73 FR 13240), 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
58.35(b)(7) 300 60.25 18,075 1 18,075
--------------------------------------------------------------------------------------------------------------------------------------------------------
58.185 300 60.25 18,075 27.65 499,774
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 517,849
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 Recordkeeping Records Record Total Hours
----------------------------------------------------------------------------------------------------------------
58.29(b) 300 20 6,000 .21 1,260
----------------------------------------------------------------------------------------------------------------
58.35(b)(1) 300 270.76 81,228 3.36 272,926
through (b)(6)
and (c)
----------------------------------------------------------------------------------------------------------------
58.63(b) and (c) 300 60 18,000 .09 1,620
----------------------------------------------------------------------------------------------------------------
58.81(a) through 300 301.8 90,540 .14 12,676
(c)
----------------------------------------------------------------------------------------------------------------
58.90(c) and (g) 300 62.7 18,810 .13 2,445
----------------------------------------------------------------------------------------------------------------
58.105(a) and (b) 300 5 1,500 11.8 17,700
----------------------------------------------------------------------------------------------------------------
58.107(d) 300 1 300 4.25 1,275
----------------------------------------------------------------------------------------------------------------
58.113(a) 300 15.33 4,599 6.8 31,273
----------------------------------------------------------------------------------------------------------------
58.120 300 15.38 4,614 32.7 150,878
----------------------------------------------------------------------------------------------------------------
58.195 300 251.5 75,450 3.9 294,255
----------------------------------------------------------------------------------------------------------------
Total 786,308
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 36533]]
Dated: June 20, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14535 Filed 6-26-08; 8:45 am]
BILLING CODE 4160-01-S
