Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees, 11786-11788 [2011-4741]
Download as PDF
<![CDATA[
srobinson on DSKHWCL6B1PROD with NOTICES
11786
Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices
canned food, processors of acidified
food, and processors of both types of
food. Thus, we estimate the number of
processors keeping records under parts
113 and 114 to be 9,500, as shown in
table 2, row 1 of this document. In the
final rule, we estimated that there are
approximately 8,450 foreign and
domestic low-acid canned food
processing establishments. This
estimate, which does not encompass
establishments that process only
acidified foods (because such processors
are not affected by the final rule), was
based on data in the LACF database as
of September 2009. As discussed in the
explanation of the recordkeeping
estimate for the final rule in the
following paragraphs, our estimate
assumes that half of the LACF industry
currently does not record all of the
device accuracy testing information that
the final rule requires. Thus, as shown
in table 2, row 2 of this document, we
estimate that 4,225 low-acid canned
food manufacturers that are not
currently keeping the records that are
required under the final rule will begin
to keep such records to comply with the
final rule when it becomes effective.
FDA bases its estimates of the number
of recordkeepers and the hours per
record on its experience and on
information from industry. FDA
estimates that it takes 250 hours per
respondent to comply with the
recordkeeping requirements in parts 113
and 114. In table 2, row 1 of this
document, FDA estimates the total
burden of recordkeeping under parts
113 and 114 before the effective date of
the final rule to be 2,375,000 hours
(9,500 respondents × 250 hours =
2,375,000 hours). Table 2, row 2 reports
the average annual recordkeeping
burden of the final rule. The burden of
the recordkeeping requirement of the
final rule consists of the set-up time
required to design and establish a form
for recording the required information,
and the additional hours of labor
needed to record the information. The
set-up time required for designing a new
recordkeeping form is assumed to be
minimal because we estimate that only
a few data elements required in the final
rule are currently unreported by some
processors and that only small
modifications to a processor’s
recordkeeping form would be required
to accommodate the additional data
elements.
We estimate that the amount of time
needed to comply with the
recordkeeping requirements of the final
rule will be small because current
industry practice is to keep track of
most, if not all, of this information.
Because current incentives to track
VerDate Mar<15>2010
16:47 Mar 02, 2011
Jkt 223001
accuracy of mercury-in-glass
thermometers may vary across the
industry, however, some information
that is currently generated during
accuracy tests may not be recorded as
required under the final rule. Thus, we
assume there will be a burden incurred
from the final rule to record information
that is currently generated, but not
recorded.
We assume that half of the industry
currently does not record all of the
device accuracy testing information that
the final rule requires. We further
assume that current practice by these
firms is to leave unrecorded 1 to 4
separate pieces of information required
under the final rule, and that each piece
of information takes between 10 and 15
seconds to record. Consequently, we
estimate that half of all low-acid canned
food manufacturers will spend between
10 seconds and 1 minute (i.e., 1 × 10
seconds and 4 × 15 seconds) per device
to record information required in the
final rule.
Based on a survey conducted by FDA
between 1992 and 1993 of mercury-inglass thermometer calibration in the
low-acid canned food industry, we
estimate that low-acid food firms use an
average of 10 temperature-indicating
devices, including reference devices.
We estimate that 4,225 low-acid canned
food manufacturers (half of the
industry) currently do not fully record
the accuracy test results required by the
final rule. Because the regulations
specify that each device must be tested
upon installation and at least once per
year thereafter, or more frequently if
necessary to ensure accuracy, we
estimate that each device requires 1 to
2 tests per year (midpoint of 1.5 tests
per year). We therefore estimate the
annual frequency per recordkeeping to
be 15 (i.e., 10 devices × 1.5 tests per
year). We estimate the burden for
recording the additional information to
be between 10 and 60 seconds per
device (midpoint of 35 seconds or
0.0097 hours per device). Therefore, the
estimated total annual burden in hours
for the recordkeeping requirements of
the final rule is approximately 615
hours (63,375 × 0.0097 = 614.7 hours,
rounded to 615 hours). Thus, the final
rule increases the total burden of this
information collection by approximately
0.3 percent, from 2,375,000 hours to
2,375,615 hours.
Dated: February 23, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2011–4474 Filed 3–2–11; 8:45 am]
BILLING CODE 4160–01–P
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0583]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Radioactive Drug
Research Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by April 4,
2011.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0053. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
Radioactive Drug Research
Committees—(OMB Control Number
0910–0053)—Extension
Under sections 201, 505, and 701 of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321, 355, and 371), FDA
has the authority to issue regulations
governing the use of radioactive drugs
for basic scientific research. Section
361.1 (21 CFR 361.1) sets forth specific
regulations regarding the establishment
and composition of Radioactive Drug
Research Committees and their role in
approving and monitoring basic
research studies utilizing
radiopharmaceuticals. No basic research
E:\FR\FM\03MRN1.SGM
03MRN1
11787
Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices
study involving any administration of a
radioactive drug to research subjects is
permitted without the authorization of
an FDA-approved Radioactive Drug
Research Committee (§ 361.1(d)(7)). The
type of research that may be undertaken
with a radiopharmaceutical drug must
be intended to obtain basic information
and not to carry out a clinical trial for
safety or efficacy. The types of basic
research permitted are specified in the
regulation, and include studies of
metabolism, human physiology,
pathophysiology, or biochemistry.
Section 361.1(c)(2) requires that each
Radioactive Drug Research Committee
shall select a chairman, who shall sign
all applications, minutes, and reports of
the committee. Each committee shall
meet at least once each quarter in which
research activity has been authorized or
conducted. Minutes shall be kept and
shall include the numerical results of
votes on protocols involving use in
human subjects. Under § 361.1(c)(3),
each Radioactive Drug Research
Committee shall submit an annual
report to FDA. The annual report shall
include the names and qualifications of
the members of, and of any consultants
used by, the Radioactive Drug Research
Committee, using FDA Form 2914, and
a summary of each study conducted
during the proceeding year, using FDA
Form 2915.
Under § 361.1(d)(5), each investigator
shall obtain the proper consent required
under the regulations. Each female
research subject of childbearing
potential must state in writing that she
is not pregnant, or on the basis of a
pregnancy test be confirmed as not
pregnant.
Under § 361.1(d)(8), the investigator
shall immediately report to the
Radioactive Drug Research Committee
all adverse effects associated with use of
the drug, and the committee shall then
report to FDA all adverse reactions
probably attributed to the use of the
radioactive drug.
Section 361.1(f) sets forth labeling
requirements for radioactive drugs.
These requirements are not in the
reporting burden estimate because they
are information supplied by the Federal
Government to the recipient for the
purposes of disclosure to the public (5
CFR 1320.3(c)(2)).
Types of research studies not
permitted under this regulation are also
specified, and include those intended
for immediate therapeutic, diagnostic,
or similar purposes or to determine the
safety or effectiveness of the drug in
humans for such purposes (i.e., to carry
out a clinical trial for safety or efficacy).
These studies require filing of an
investigational new drug application
(IND) under 21 CFR part 312, and the
associated information collections are
covered in OMB control number 0910–
0014.
The primary purpose of this
collection of information is to determine
whether the research studies are being
conducted in accordance with required
regulations and that human subject
safety is assured. If these studies were
not reviewed, human subjects could be
subjected to inappropriate radiation or
pharmacologic risks.
Respondents to this information
collection are the chairperson(s) of each
individual Radioactive Drug Research
Committee, investigators, and
participants in the studies.
The burden estimates are based on
FDA’s experience with these reporting
and recordkeeping requirements over
the past few years and the number of
submissions received by FDA under the
regulations.
In the Federal Register of November
30, 2010 (75 FR 74059), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Annual frequency per
response
Number of
respondents
Total annual
responses
Hours per
response
21 CFR section
Forms
361.1(c)(3) and (4) ............................
361.1(c)(3) ........................................
361.1(d)(8) ........................................
FDA 2914 .....................
FDA 2915 .....................
.......................................
80
50
50
1
6.8
6.8
80
340
340
1
3.5
0.1
80
1,190
34
Total ...........................................
.......................................
........................
....................
........................
....................
1,304
1 There
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Annual frequency per
recordkeeping
361.1(c)(2) ........................................................................................
361.1(d)(5) .......................................................................................
80
50
4
6.8
320
340
10
0.75
3,200
255
Total ..........................................................................................
........................
........................
........................
............
3,455
21 CFR section
srobinson on DSKHWCL6B1PROD with NOTICES
1 There
Total annual
records
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Mar<15>2010
16:47 Mar 02, 2011
Jkt 223001
PO 00000
Frm 00037
Fmt 4703
Sfmt 9990
E:\FR\FM\03MRN1.SGM
03MRN1
Hours
per
records
Total hours
11788
Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices
Dated: February 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–4741 Filed 3–2–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0098]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Infant Formula
Label Statements Experimental Study
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 study entitled ‘‘Infant Formula Label
Statements Experimental Study.’’
DATES: Submit either electronic or
written comments on the collection of
information by May 2, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. 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:
Denver Presley, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
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.
srobinson on DSKHWCL6B1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:47 Mar 02, 2011
Jkt 223001
‘‘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 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.
Infant Formula Label Statements
Experimental Study—(OMB Control
Number 0910–NEW)
FDA is planning to conduct an
experimental study about certain types
of label statements on infant formula,
such as those that are either structure
function claims or similar to such
claims. An example of the type of
statements that are of interest is:
‘‘Supports brain and eye development.’’
The Infant Formula Label Statements
Experimental Study will collect
information from four groups: Pregnant
women, mothers of infants less than 12
months old, mothers of children older
than 1 year but younger than 5 years
old, and women of childbearing age
who do not have a child younger than
5 years. The purpose of the study is to
assess women’s understanding of and
response to various statements on infant
formula labels. The study results will be
used to help the Agency to understand
the role that certain types of statements
on infant formula labels have in
influencing formula choice.
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
The data will be collected over the
Internet from a sample of 5,000 adult
women selected from an online
consumer panel. Participants will be
randomly assigned to an experimental
condition. The study will show
participants one of five explanations of
the regulatory, scientific, or marketing
context (or none of these) of infant
formula marketing in the United States
and will ask them to compare two sets
of two experimental infant formula
labels. One label will always be a
control label with no statement similar
to a structure function claim. The other
label will include one of the statements
of interest to the study. The study will
focus on purchase choice, perceived
similarity of the formula to breast milk,
and perceived likelihood that the
formula has certain health benefits. In
addition, information about certain
covariates will be collected, depending
on the group the participant is in.
Covariate information will include, as
appropriate, month of pregnancy, plans
for feeding the infant, number of
children, age of youngest child, whether
the youngest child was fed infant
formula, whether the youngest child
was ever breast fed, whether the mother
bought infant formula for her youngest
child, priorities used to select the
formula purchased, and attitudes about
the differences between breast milk and
formula. Participation in the study is
voluntary.
Approximately 10,000 women will be
screened. We estimate that it will take
a respondent 20 seconds (0.0055 hours)
to complete the screening questions, for
a total of 55 hours. A pretest will be
conducted with 150 participants. We
estimate that it will take a respondent
15 minutes (0.25 hours) to complete the
experiment and 10 minutes (0.167
hours) to complete debriefing questions
for the pretest, for a total of 25 minutes
(0.42 hours) per respondent and a total
of 63 hours for the pretest. Five
thousand (5,000) adult women will
complete the experiment. We estimate
that it will take a respondent 15 minutes
(0.25 hours) to complete the entire
experiment, for a total of 1,250 hours.
Thus, the total estimated burden is
1,368 hours. FDA’s burden estimate is
based on prior experience with
consumer experiments that are similar
to this proposed experiment.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\03MRN1.SGM
03MRN1
]]>Agencies
[Federal Register Volume 76, Number 42 (Thursday, March 3, 2011)]
[Notices]
[Pages 11786-11788]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4741]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0583]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Radioactive Drug
Research Committees
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 April
4, 2011.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0053.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3792,
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Radioactive Drug Research Committees--(OMB Control Number 0910-0053)--
Extension
Under sections 201, 505, and 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 355, and 371), FDA has the authority to
issue regulations governing the use of radioactive drugs for basic
scientific research. Section 361.1 (21 CFR 361.1) sets forth specific
regulations regarding the establishment and composition of Radioactive
Drug Research Committees and their role in approving and monitoring
basic research studies utilizing radiopharmaceuticals. No basic
research
[[Page 11787]]
study involving any administration of a radioactive drug to research
subjects is permitted without the authorization of an FDA-approved
Radioactive Drug Research Committee (Sec. 361.1(d)(7)). The type of
research that may be undertaken with a radiopharmaceutical drug must be
intended to obtain basic information and not to carry out a clinical
trial for safety or efficacy. The types of basic research permitted are
specified in the regulation, and include studies of metabolism, human
physiology, pathophysiology, or biochemistry.
Section 361.1(c)(2) requires that each Radioactive Drug Research
Committee shall select a chairman, who shall sign all applications,
minutes, and reports of the committee. Each committee shall meet at
least once each quarter in which research activity has been authorized
or conducted. Minutes shall be kept and shall include the numerical
results of votes on protocols involving use in human subjects. Under
Sec. 361.1(c)(3), each Radioactive Drug Research Committee shall
submit an annual report to FDA. The annual report shall include the
names and qualifications of the members of, and of any consultants used
by, the Radioactive Drug Research Committee, using FDA Form 2914, and a
summary of each study conducted during the proceeding year, using FDA
Form 2915.
Under Sec. 361.1(d)(5), each investigator shall obtain the proper
consent required under the regulations. Each female research subject of
childbearing potential must state in writing that she is not pregnant,
or on the basis of a pregnancy test be confirmed as not pregnant.
Under Sec. 361.1(d)(8), the investigator shall immediately report
to the Radioactive Drug Research Committee all adverse effects
associated with use of the drug, and the committee shall then report to
FDA all adverse reactions probably attributed to the use of the
radioactive drug.
Section 361.1(f) sets forth labeling requirements for radioactive
drugs. These requirements are not in the reporting burden estimate
because they are information supplied by the Federal Government to the
recipient for the purposes of disclosure to the public (5 CFR
1320.3(c)(2)).
Types of research studies not permitted under this regulation are
also specified, and include those intended for immediate therapeutic,
diagnostic, or similar purposes or to determine the safety or
effectiveness of the drug in humans for such purposes (i.e., to carry
out a clinical trial for safety or efficacy). These studies require
filing of an investigational new drug application (IND) under 21 CFR
part 312, and the associated information collections are covered in OMB
control number 0910-0014.
The primary purpose of this collection of information is to
determine whether the research studies are being conducted in
accordance with required regulations and that human subject safety is
assured. If these studies were not reviewed, human subjects could be
subjected to inappropriate radiation or pharmacologic risks.
Respondents to this information collection are the chairperson(s)
of each individual Radioactive Drug Research Committee, investigators,
and participants in the studies.
The burden estimates are based on FDA's experience with these
reporting and recordkeeping requirements over the past few years and
the number of submissions received by FDA under the regulations.
In the Federal Register of November 30, 2010 (75 FR 74059), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
Number of frequency Total annual Hours per
21 CFR section Forms respondents per responses response Total hours
response
--------------------------------------------------------------------------------------------------------------------------------------------------------
361.1(c)(3) and (4).......................... FDA 2914....................... 80 1 80 1 80
361.1(c)(3).................................. FDA 2915....................... 50 6.8 340 3.5 1,190
361.1(d)(8).................................. ............................... 50 6.8 340 0.1 34
----------------------------------------------------------------------------------------------------------
Total.................................... ............................... .............. ........... .............. ........... 1,304
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual Hours
21 CFR section Number of frequency per Total annual per Total hours
recordkeepers recordkeeping records records
----------------------------------------------------------------------------------------------------------------
361.1(c)(2)............................. 80 4 320 10 3,200
361.1(d)(5)............................. 50 6.8 340 0.75 255
-----------------------------------------------------------------------
Total............................... .............. ............. .............. ....... 3,455
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 11788]]
Dated: February 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-4741 Filed 3-2-11; 8:45 am]
BILLING CODE 4160-01-P
