Agency Information Collection Activities: Proposed Collection; Comment Request; Radioactive Drug Research Committees, 4348-4350 [2014-01463]
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Federal Register / Vol. 79, No. 17 / Monday, January 27, 2014 / Notices
processors of fruit and vegetable juices
establish and follow a preplanned
sequence of operations and observations
(the HACCP plan) designed to avoid or
eliminate one or more specific food
hazards, and thereby ensure that their
products are safe, wholesome, and not
adulterated; in compliance with section
402 of the FD&C Act. Information
development and recordkeeping are
essential parts of any HACCP system.
The information collection requirements
are narrowly tailored to focus on the
development of appropriate controls
and document those aspects of
processing that are critical to food
safety.
In the Federal Register of November
20, 2013 (78 FR 69689), 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 RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
120.6(c) and 120.12(a)(1) and (b); Require written monitoring and correction records for Sanitation
Standard
Operating
Procedures
(SSOPs).
120.7 and 120.12(a)(2), (b) and (c); Require written hazard analysis of food hazards.
120.8(b)(7) and 120.12(a)(4)(i) and (b); Require
a recordkeeping system that documents monitoring of the critical control points and other
measurements as prescribed in the HACCP
plan.
120.10(c) and 120.12(a)(4)(ii) and (b); Require
that all corrective actions taken in response to
a deviation from a critical limit be documented.
120.11(a)(1)(iv) and (a)(2), 120.12(a)(5); Require
records showing that process monitoring instruments are properly calibrated and that endproduct or in-process testing is performed in
accordance with written procedures.
120.11(b) and 120.12(a)(5) and (b); Require that
every processor record the validation that the
HACCP plan is adequate to control food hazards that are likely to occur.
120.14(a)(2), (c), and (d); Require that importers
of fruit or vegetable juices, or their products
used as ingredients in beverages, have written
procedures to ensure that the food is processed in accordance with our regulations in
part 120.
120.11(c) and 120.12(a)(5) and (b); Require documentation of revalidation of the hazard analysis upon any changes that might affect the
original hazard analysis (applies when a firm
does not have an HACCP plan because the
original hazard analysis did not reveal hazards
likely to occur).
1,875
365
684,375
0.1 (8 minutes) .............
68,438
2,300
1.1
2,530
20 ..................................
50,600
1,450
14,600
21,170,000
0.01 (1 minute) .............
211,700
1,840
12
22,080
0.1 (8 minutes) .............
2,208
1,840
52
95,680
0.1 (8 minutes) .............
9,568
1,840
1
1,840
4 ....................................
7,360
308
1
308
4 ....................................
1,232
1,840
1
1,840
4 ....................................
7,360
Total ...............................................................
........................
........................
........................
.......................................
358,466
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1
There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 1 provides our estimate of the
total annual recordkeeping burden of
our regulations in part 120. We base our
estimate of the average burden per
recordkeeping on our experience with
the application of HACCP principles in
food processing. We base our estimate of
the number of recordkeepers on our
estimate of the total number of juice
manufacturing plants affected by the
regulations (plants identified in our
official establishment inventory plus
very small apple juice and very small
orange juice manufacturers). These
estimates assume that every processor
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will prepare sanitary standard operating
procedures and an HACCP plan and
maintain the associated monitoring
records, and that every importer will
require product safety specifications. In
fact, there are likely to be some small
number of juice processors that, based
upon their hazard analysis, determine
that they are not required to have an
HACCP plan under these regulations.
Dated: January 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–01462 Filed 1–24–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–N–0383]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Radioactive Drug
Research Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\27JAN1.SGM
Notice.
27JAN1
Federal Register / Vol. 79, No. 17 / Monday, January 27, 2014 / Notices
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, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection contained in
regulations governing the use of
radioactive drugs for basic informational
research.
DATES: Submit either electronic or
written comments on the collection of
information by March 28, 2014.
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing 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.
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SUMMARY:
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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.
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 (RDRC) and their
role in approving and monitoring basic
research studies utilizing
radiopharmaceuticals. No basic research
study involving any administration of a
radioactive drug to research subjects is
permitted without the authorization of
an FDA approved RDRC (§ 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
RDRC 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 RDRC shall submit an
annual report to FDA. The annual report
shall include the names and
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4349
qualifications of the members of, and of
any consultants used by, the RDRC,
using Form FDA 2914, and a summary
of each study conducted during the
preceding year, using Form FDA 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 RDRC 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 RDRC, 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.
FDA estimates the burden of this
collection of information as follows:
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27JAN1
4350
Federal Register / Vol. 79, No. 17 / Monday, January 27, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR sections/forms
Total annual
responses
Average burden
per response
Total hours
361.1(c)(3)&(4); Form FDA 2914 ......
361.1(c)(3); Form FDA 2915 ............
361.1(d)(8) ........................................
69
48
10
1
10
5
69
480
50
1 .......................................................
3.5 ....................................................
0.5 (30 minutes) ...............................
69
1,680
25
Total ...........................................
........................
........................
........................
...........................................................
1,774
1 There
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
21 CFR section
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
361.1(c)(2) .........................................
361.1(d)(5) ........................................
69
35
4
18
276
630
10 .....................................................
0.75 ..................................................
(45 minutes) .....................................
2,760
472.5
Total ...........................................
........................
........................
........................
...........................................................
3,232.5
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
comments should be identified with the
OMB control number 0910–0609. Also
include the FDA docket number found
in brackets in the heading of this
document.
[FR Doc. 2014–01463 Filed 1–24–14; 8:45 am]
BILLING CODE 4160–01–P
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@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.
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1432]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guide To Minimize
Microbial Food Safety Hazards of
Fresh-Cut Fruits and Vegetables
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
(the PRA).
DATES: Fax written comments on the
collection of information by February
26, 2014.
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 emailed to oira_
submission@omb.eop.gov. All
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SUMMARY:
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Guide To Minimize Microbial Food
Safety Hazards of Fresh-Cut Fruits and
Vegetables (OMB Control Number
0910–0609)—Extension
Fresh-cut fruits and vegetables are
fruits and vegetables that have been
processed by peeling, slicing, chopping,
shredding, coring, trimming, or
mashing, with or without washing or
other treatment, prior to being packaged
for consumption. The methods by
which produce is grown, harvested, and
processed may contribute to its
contamination with pathogens and,
consequently, the role of the produce in
transmitting foodborne illness. Factors
such as the high degree of handling and
mixing of the product, the release of
cellular fluids during cutting or
mashing, the high moisture content of
the product, the absence of a step lethal
to pathogens, and the potential for
temperature abuse in the processing,
storage, transport, and retail display all
increase the potential for pathogens to
survive and grow in fresh-cut produce.
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Sections 301 and 402 of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 331 and 342)
prohibits the distribution of adulterated
food in interstate commerce. In response
to the increased consumption of freshcut fruits and vegetables and the
potential for foodborne illness
associated with these products, we
recognize the need for guidance specific
to the processing of fresh-cut fruits and
vegetables. The guidance document
entitled ‘‘Guide to Minimize Microbial
Food Safety Hazards of Fresh-cut Fruits
and Vegetables,’’ which is available at
https://www.fda.gov/FoodGuidances,
provides our recommendations to freshcut produce processors about how to
avoid contamination of their product
with pathogens. The guidance is in
addition to the good manufacturing
practice (GMP) regulations found in part
110 (21 CFR part 110). The guidance is
intended to assist fresh-cut produce
processors in minimizing microbial food
safety hazards common to the
processing of most fresh-cut fruits and
vegetables sold to consumers and retail
establishments in a ready-to-eat form.
Accordingly, we encourage fresh-cut
produce processors to adopt the general
recommendations in the guidance and
to tailor practices to their individual
operations.
The guidance provides information
and recommended procedures designed
to help fresh-cut produce processors
minimize microbial food safety hazards.
The recommended procedures
contained in the guidance are voluntary.
Both FDA and fresh-cut produce
processors will use and benefit from the
information collected.
E:\FR\FM\27JAN1.SGM
27JAN1
]]>Agencies
[Federal Register Volume 79, Number 17 (Monday, January 27, 2014)]
[Notices]
[Pages 4348-4350]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01463]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-N-0383]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Radioactive Drug Research Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 4349]]
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
contained in regulations governing the use of radioactive drugs for
basic informational research.
DATES: Submit either electronic or written comments on the collection
of information by March 28, 2014.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing 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.
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 (RDRC) and their role in approving and
monitoring basic research studies utilizing radiopharmaceuticals. No
basic research study involving any administration of a radioactive drug
to research subjects is permitted without the authorization of an FDA
approved RDRC (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 RDRC 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 RDRC
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 RDRC, using Form FDA 2914, and a summary of each study
conducted during the preceding year, using Form FDA 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 RDRC 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 RDRC, 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.
FDA estimates the burden of this collection of information as
follows:
[[Page 4350]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR sections/forms Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
361.1(c)(3)&(4); Form FDA 2914 69 1 69 1............... 69
361.1(c)(3); Form FDA 2915.... 48 10 480 3.5............. 1,680
361.1(d)(8)................... 10 5 50 0.5 (30 minutes) 25
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 1,774
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
361.1(c)(2)................... 69 4 276 10.............. 2,760
361.1(d)(5)................... 35 18 630 0.75............ 472.5
(45 minutes)....
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 3,232.5
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: January 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01463 Filed 1-24-14; 8:45 am]
BILLING CODE 4160-01-P
