Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs For Investigational Use, 20570-20571 [05-7823]
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20570
Federal Register / Vol. 70, No. 75 / Wednesday, April 20, 2005 / Notices
gather evidence on whether a labeling
statement on a specific product
marketed in a specific context could
produce the alleged harm and the harm
is material.
In addition to protecting consumer
health from harms caused by deceptive
product labeling, however, the agency’s
mission also calls for advancing
consumer health by providing
information about food products to help
consumers improve their health and
decrease the risk of contracting diseases
by making sound dietary choices. The
study was proposed with this mission in
mind and, therefore, neither intends,
nor is designed to demonstrate any
harm attributable to any specific health
messages on any specific products. As
stated in the 60-day notice, the study
will hold back-panel information (e.g.,
nutrient contents) constant between
front-panel conditions for a given food
product. Furthermore, the nutrient
contents of test products will meet
current regulatory standards for various
health messages. Therefore, by design,
the study approach precludes any
attempt to examine any potential harm
as purported in the comment. Instead,
the study approach is commonly used
and accepted by researchers for the
purpose of investigating communication
efficacy of label stimuli.
Health messages such as health claims
are intended for use by all qualifying
marketers and in all qualifying
products, rather than certain specific
marketers or products. Hence, under the
agency’s regulatory regime, the study
does not intend to examine specific
claims on specific products in specific
contexts, as individual marketers would
do. Rather, the study will attempt to
illustrate possible consumer responses
to different types of health messages
that may be found on packages of
various food products. Finally, the
agency notes that, despite the
discordance between experimental
contexts and the real world,
experimental findings are widely
recognized and accepted as the best
available evidence to demonstrate
communication efficacy.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Activity
Annual Frequency
per Response
Pretest
Total Annual
Responses
Hours per
Response
60
1
60
Invitation
2,000
1
Interview, Phase 1
1,060
Interview, Phase 2
1,060
0.5
30
2,000
0.02
40
1
1,060
0.17
180
1
1,060
0.25
265
Total
1 There
Total Hours
515
are no capital costs or operating and maintenance costs associated with this collection of information.
Prior to the administration of the
interview, the agency plans to conduct
pretests of the final questionnaires to
minimize potential problems in
administration of the interviews. The
pretests, each lasting 30 minutes (0.5
hours), will be conducted in up to 3
waves, each with 20 participants. A
contractor will send 2,000 e-mail
invitations to recruit participants. We
assume 50 percent of those contacted
will agree to participate in the
interviews (1,060 respondents). The
interviews are expected to last 10
minutes (0.17 hours) and 15 minutes
(0.25 hours) for phase 1 and phase 2,
respectively.
The planned sample size per
condition is approximately 120. The
agency expects small main effects.
Therefore, the planned sample size
should yield a power of 0.8 at the 0.05
significance level.
Dated: April 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–7822 Filed 4–19–05; 8:45 am]
BILLING CODE 4160–01–S
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16:34 Apr 19, 2005
Jkt 205001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N–0470]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; New Animal Drugs
For Investigational Use
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
(the PRA).
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
ADDRESSES:
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
the information collection are received,
OMB recommends that written
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:
Denver Presley, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane, rm.
4B–41, Rockville, MD 20857, 301–827–
1472.
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.
New Animal Drugs for Investigational
Use—21 CFR Part 511 (OMB Control
Number 0910–0117)—Extension
FDA has the responsibility under the
Federal Food, Drug, and Cosmetic Act
(the act), for approval of new animal
drugs. Section 512(j) of the act (21
U.S.C. 360b(j)), authorizes FDA to issue
regulations relating to the
investigational use of new animal drugs.
The regulations setting forth the
conditions for investigational use of
new animal drugs have been codified at
part 511 (21 CFR part 511). A sponsor
E:\FR\FM\20APN1.SGM
20APN1
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
]]>Agencies
[Federal Register Volume 70, Number 75 (Wednesday, April 20, 2005)]
[Notices]
[Pages 20570-20571]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7823]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0470]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; New Animal Drugs For
Investigational Use
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 (the PRA).
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 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: Denver Presley, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
rm. 4B-41, Rockville, MD 20857, 301-827-1472.
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.
New Animal Drugs for Investigational Use--21 CFR Part 511 (OMB Control
Number 0910-0117)--Extension
FDA has the responsibility under the Federal Food, Drug, and
Cosmetic Act (the act), for approval of new animal drugs. Section
512(j) of the act (21 U.S.C. 360b(j)), authorizes FDA to issue
regulations relating to the investigational use of new animal drugs.
The regulations setting forth the conditions for investigational use of
new animal drugs have been codified at part 511 (21 CFR part 511). A
sponsor
[[Page 20571]]
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 Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses 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 21,824
----------------------------------------------------------------------------------------------------------------
\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
----------------------------------------------------------------------------------------------------------------
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 12,798
----------------------------------------------------------------------------------------------------------------
\1\ There 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]
BILLING CODE 4160-01-S
