Agency Information Collection Activities: Proposed Collection; Comment Request; Current Good Manufacturing Practice for Positron Emission Tomography Drugs, 17215-17217 [2013-06351]
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Federal Register / Vol. 78, No. 54 / Wednesday, March 20, 2013 / Notices
Living) has submitted the following
proposed collection of information to
OMB for review and clearance.
The ‘‘Empowering Older Adults and
Adults with Disabilities through
Chronic Disease Self-Management
Education (CDSME) Programs’’
cooperative agreement program is
financed through 2012 Prevention and
Public Health Funds. The proposed data
collection is necessary for monitoring
grant program operations and outcomes.
AoA proposes to gather information to
monitor grantee progress, record
location of sites where workshops are
held which will allow mapping of the
delivery infrastructure, and document
participant attendance and demographic
and health characteristics. The proposed
Participant Survey requests the
participants’ gender, zip code and
birthdate to allow for potential Medicare
claims matching and an analysis of
changes in health care utilization post
participation.
In response to the 60-day Federal
Register notice related to this proposed
data collection and published on July
23, 2013, four sets of comments were
received. Concern was expressed about
the collection of sensitive personal
information. Most of the remaining
comments provided suggestions for
enhancing the quality and clarity of the
information to be collected. The
comments resulted in some revisions to
the proposed data collection tools. The
originally proposed data collection
tools, the comments with responses and
a revised set of data collection tools may
be found on the AoA Web site at:
https://www.aoa.gov/AoARoot/
AoA_Programs/Tools_Resources/
collection_tools.aspx.
ACL estimates the burden of this
collection of information as 440 hours
for State Governments, 1050 hours for
local agency staff, and 2,500 hours for
individuals—Total burden is 3,990
hours per year.
Dated: March 15, 2013.
Kathy Greenlee,
Administrator and Assistant Secretary for
Aging.
[FR Doc. 2013–06390 Filed 3–19–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0242]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Current Good
Manufacturing Practice for Positron
Emission Tomography Drugs
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
FDA’s regulations on current good
manufacturing practice (CGMP) for
positron emission tomography (PET)
drugs.
DATES: Submit either electronic or
written comments on the collection of
information by May 20, 2013.
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: Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., P150–
400B, Rockville, MD 20850, 301–796–
7726, Ila.mizrachi@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.
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17215
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.
Current Good Manufacturing Practice
for Positron Emission Tomography
Drugs—(OMB Control Number 0910–
0667)—Extension
Positron emission tomography is a
medical imaging modality involving the
use of a unique type of
radiopharmaceutical drug product.
FDA’s CGMP regulations at 21 CFR part
212 are intended to ensure that PET
drug products meet the requirements of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) regarding safety,
identity, strength, quality, and purity.
The CGMP requirements for PET drugs
are issued under the provisions of the
Food and Drug Administration
Modernization Act (FDAMA). These
CGMP requirements are designed to take
into account the unique characteristics
of PET drugs, including their short halflives and the fact that most PET drugs
are produced at locations that are very
close to the patients to whom the drugs
are administered.
The CGMP regulations are intended to
ensure that approved PET drugs meet
the requirements of the FD&C Act as to
safety, identity, strength, quality, and
purity. The regulations address the
following matters: Personnel and
resources; quality assurance; facilities
and equipment; control of components,
in-process materials, and finished
products; production and process
controls; laboratory controls; acceptance
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Federal Register / Vol. 78, No. 54 / Wednesday, March 20, 2013 / Notices
criteria; labeling and packaging controls;
distribution controls; complaint
handling; and recordkeeping.
The CGMP regulations establish
several recordkeeping requirements and
a third-party disclosure requirement for
the production of PET drugs. In making
our estimates of the time spent in
complying with these information
collection requirements, we relied on
communications we have had with PET
producers, visits by our staff to PET
facilities, and our familiarity with both
PET and general pharmaceutical
manufacturing practices. The estimated
annual recordkeeping and third-party
disclosure burden is based on there
being approximately 129 PET drug
production facilities. Table 1 provides
an estimate of the annual recordkeeping
burdens. Table 2 provides an estimate of
the annual third-party disclosure
burdens associated with this collection.
A. Investigational and Research PET
Drugs
Section 212.5(b)(2) provides that for
investigational PET drugs produced
under an investigational new drug (IND)
and research PET drugs produced with
approval of a Radioactive Drug Research
Committee (RDRC), the requirement
under the FD&C Act to follow current
good manufacturing practice is met by
complying with the regulations in part
212 or with USP 32 Chapter 823. We
believe that PET production facilities
producing drugs under INDs and RDRCs
are currently substantially complying
with the recordkeeping requirements of
USP 32 Chapter 823 (see section 121(b)
of the FDAMA), and accordingly, we do
not estimate any recordkeeping burden
for this provision.
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B. Batch Production and Control
Records
Sections 212.20(c) through (e),
212.50(a) through (c), and 212.80(c) set
forth requirements for batch and
production records as well as written
control records. We estimate that it
would take approximately 20 hours
annually for each PET production
facility to prepare and maintain written
production and control procedures and
to create and maintain master batch
records for each PET drug produced. We
also estimate that there will be a total of
approximately 221 PET drugs produced,
with a total recordkeeping burden of
approximately 4,420 hours. We estimate
that it would take a PET production
facility an average of 30 minutes to
complete a batch record for each of
approximately 501 batches. Our
estimated burden for completing batch
records is approximately 32,315 hours.
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C. Equipment and Facilities Records
Sections 212.20(c), 212.30(b),
212.50(d), and 212.60(f) contain
requirements for records dealing with
equipment and physical facilities. We
estimate that it would take
approximately 1 hour to establish and
maintain these records for each piece of
equipment in each PET production
facility. We estimate that the total
burden for establishing procedures for
these records would be approximately
1,935 hours. We estimate that recording
maintenance and cleaning information
would take approximately 5 minutes a
day for each piece of equipment, with
a total recordkeeping burden of
approximately 40,237 hours.
test results is approximately 10,728
hours.
G. Sterility Test Failure Notices
Section 212.70(e) requires PET drug
producers to notify all receiving
facilities if a batch fails sterility tests.
We believe that sterility test failures
might occur in only 0.05 percent of the
batches of PET drugs produced each
year. Therefore, we have estimated in
Table 2 that each PET drug producer
will need to provide approximately 0.25
sterility test failure notice per year to
receiving facilities. The notice would be
provided using email or facsimile
transmission and should take no more
than 1 hour.
D. Records of Components, Containers,
and Closures
Sections 212.20(c) and 212.40(a), (b),
and (e) contain requirements on records
regarding receiving and testing of
components, containers, and closures.
We estimate that the annual burden for
establishing these records would be
approximately 259 hours. We estimate
that each facility would receive
approximately 36 shipments annually
and would spend approximately 10
minutes per shipment entering records.
The annual burden for maintaining
these records would be approximately
771 hours.
E. Process Verification
Section 212.50(f)(2) requires that any
process verification activities and
results be recorded. Because process
verification is only required when
results of the production of an entire
batch are not fully verified through
finished-product testing, we believe that
process verification will be a very rare
occurrence, and we do not estimate any
recordkeeping burden for documenting
process verification.
F. Laboratory Testing Records
Sections 212.20(c), 212.60(a), (b), and
(g), 212.61(a) through (b), and 212.70(a),
(b), and (d) set out requirements for
documenting laboratory testing and
specifications referred to in laboratory
testing, including final release testing
and stability testing. Each PET drug
production facility will need to
establish procedures and create forms
for the different tests for each product
they produce. We estimate that it will
take each facility an average of 1 hour
to establish procedures and create forms
for one test. The estimated annual
burden for establishing procedures and
creating forms for these records is
approximately 3,225 hours, and the
annual burden for recording laboratory
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H. Conditional Final Releases
Section 212.70(f) requires PET drug
producers to document any conditional
final releases of a product. We believe
that conditional final releases will be
fairly uncommon, but for purposes of
the PRA, we estimated that each PET
production facility would have one
conditional final release a year and
would spend approximately 1 hour
documenting the release and notifying
receiving facilities. The estimate of one
conditional final release per year per
facility is an appropriate average
number because many facilities may
have no conditional final releases while
others might have only a few.
I. Out-of-Specification Investigations
Sections 212.20(c) and 212.71(a) and
(b) require PET drug producers to
establish procedures for investigating
products that do not conform to
specifications and conduct these
investigations as needed. We estimate
that it will take approximately 1 hour
annually to record and update these
procedures for each PET production
facility. We also estimate, for purposes
of the PRA, that 36 out-of-specification
investigations would be conducted at
each facility each year and that it would
take approximately 1 hour to document
the investigation, which results in an
annual burden of 4,644 hours.
J. Reprocessing Procedures
Sections 212.20(c) and 212.71(d)
require PET drug producers to establish
and document procedures for
reprocessing PET drugs. We estimate
that it will take approximately 1 hour a
year to document these procedures for
each PET production facility. We do not
estimate a separate burden for recording
the actual reprocessing, both because we
believe it would be an uncommon event
and because the recordkeeping burden
has been included in our estimate for
batch production and control records.
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K. Distribution Records
Sections 212.20(c) and 212.90(a)
require that written procedures
regarding distribution of PET drug
products be established and maintained.
We estimate that it will take
approximately 1 hour annually to
establish and maintain records of these
procedures for each PET production
facility. Section 212.90(b) requires that
distribution records be maintained. We
estimate that it will take approximately
15 minutes to create an actual
distribution record for each batch of
PET drug products, with a total burden
of approximately 16,157 hours for all
PET producers.
L. Complaints
Sections 212.20(c) and 212.100
require that PET drug producers
establish written procedures for dealing
with complaints, as well as document
how each complaint is handled. We
estimate that establishing and
maintaining written procedures for
complaints will take approximately 1
hour annually for each PET production
facility and that each facility will
receive approximately one complaint a
year and will spend approximately 30
minutes recording how the complaint
was dealt with.
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
Number of
records per
recordkeeper
Total annual
records
212.20(c) and (e); 212.50(a) and (b) .....................................
212.20(d) and (e); 212.50(c); 212.80(c) .................................
129
129
1.71
501
221
64,629
212.20(c); 212.30(b); 212.50(d), 212.60(f) .............................
212.30(b); 212.50(d); 212.60(f) ..............................................
129
129
15
3,758
1,935
484,782
212.20(c); 212.40(a) and (b) ..................................................
212.40(e) ................................................................................
129
129
2
36
258
4,644
212.20(c); 212.60(a) and (b); 212.61(a); 212.70(a), (b), and
(d).
212.60(g); 212.61(b); 212.70(d)(2) and (d)(3) .......................
129
25
3,225
129
501
64,629
212.70(f) .................................................................................
212.20(c); 212.71(a) ...............................................................
212.71(b) ................................................................................
212.20(c); 212.71(d) ...............................................................
212.20(c); 212.90(a) ...............................................................
212.90(b) ................................................................................
129
129
129
129
129
129
1
36
1
1
1
501
129
4,644
129
129
129
64,629
212.20(c); 212.100(a) .............................................................
212.100(b) and (c) ..................................................................
129
129
1
1
129
129
Total ................................................................................
........................
........................
........................
1 There
Average
burden per
recordkeeper
20 ................
.5 .................
(30 min.)
1 ..................
.08 ...............
(5 min.)
1 ..................
.166 .............
(10 min.)
1 ..................
Total hours
4,420
32,315
1,935
40,237
258
771
3,225
.16 ...............
(10 min.)
1 ..................
1 ..................
1 ..................
1 ..................
1 ..................
.25 ...............
(15 min.)
1 ..................
.5 .................
(30 min.)
10,728
.....................
115,400
129
4,644
129
129
129
16,157
129
65
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR Section
Number of
respondents
Annual
frequency of
disclosure
Total
annual
disclosures
Hours per
disclosure
Total hours
212.70(e) ..............................................................................
129
.25
32
1
32
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–06351 Filed 3–19–13; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
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BILLING CODE 4160–01–P
Agency Information Collection
Activities; Proposed Collection;
Comment Request
ACTION:
Notice.
SUMMARY: In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of Title
44, United States Code, as amended by
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the Paperwork Reduction Act of 1995,
Pub. L. 104–13), the Health Resources
and Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1984.
HRSA especially requests comments
on: (1) The necessity and utility of the
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]]>Agencies
[Federal Register Volume 78, Number 54 (Wednesday, March 20, 2013)]
[Notices]
[Pages 17215-17217]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06351]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0242]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Current Good Manufacturing Practice for Positron
Emission Tomography Drugs
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 FDA's regulations on current good manufacturing practice
(CGMP) for positron emission tomography (PET) drugs.
DATES: Submit either electronic or written comments on the collection
of information by May 20, 2013.
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: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., P150-400B,
Rockville, MD 20850, 301-796-7726, Ila.mizrachi@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.
Current Good Manufacturing Practice for Positron Emission Tomography
Drugs--(OMB Control Number 0910-0667)--Extension
Positron emission tomography is a medical imaging modality
involving the use of a unique type of radiopharmaceutical drug product.
FDA's CGMP regulations at 21 CFR part 212 are intended to ensure that
PET drug products meet the requirements of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) regarding safety, identity, strength,
quality, and purity. The CGMP requirements for PET drugs are issued
under the provisions of the Food and Drug Administration Modernization
Act (FDAMA). These CGMP requirements are designed to take into account
the unique characteristics of PET drugs, including their short half-
lives and the fact that most PET drugs are produced at locations that
are very close to the patients to whom the drugs are administered.
The CGMP regulations are intended to ensure that approved PET drugs
meet the requirements of the FD&C Act as to safety, identity, strength,
quality, and purity. The regulations address the following matters:
Personnel and resources; quality assurance; facilities and equipment;
control of components, in-process materials, and finished products;
production and process controls; laboratory controls; acceptance
[[Page 17216]]
criteria; labeling and packaging controls; distribution controls;
complaint handling; and recordkeeping.
The CGMP regulations establish several recordkeeping requirements
and a third-party disclosure requirement for the production of PET
drugs. In making our estimates of the time spent in complying with
these information collection requirements, we relied on communications
we have had with PET producers, visits by our staff to PET facilities,
and our familiarity with both PET and general pharmaceutical
manufacturing practices. The estimated annual recordkeeping and third-
party disclosure burden is based on there being approximately 129 PET
drug production facilities. Table 1 provides an estimate of the annual
recordkeeping burdens. Table 2 provides an estimate of the annual
third-party disclosure burdens associated with this collection.
A. Investigational and Research PET Drugs
Section 212.5(b)(2) provides that for investigational PET drugs
produced under an investigational new drug (IND) and research PET drugs
produced with approval of a Radioactive Drug Research Committee (RDRC),
the requirement under the FD&C Act to follow current good manufacturing
practice is met by complying with the regulations in part 212 or with
USP 32 Chapter 823. We believe that PET production facilities producing
drugs under INDs and RDRCs are currently substantially complying with
the recordkeeping requirements of USP 32 Chapter 823 (see section
121(b) of the FDAMA), and accordingly, we do not estimate any
recordkeeping burden for this provision.
B. Batch Production and Control Records
Sections 212.20(c) through (e), 212.50(a) through (c), and
212.80(c) set forth requirements for batch and production records as
well as written control records. We estimate that it would take
approximately 20 hours annually for each PET production facility to
prepare and maintain written production and control procedures and to
create and maintain master batch records for each PET drug produced. We
also estimate that there will be a total of approximately 221 PET drugs
produced, with a total recordkeeping burden of approximately 4,420
hours. We estimate that it would take a PET production facility an
average of 30 minutes to complete a batch record for each of
approximately 501 batches. Our estimated burden for completing batch
records is approximately 32,315 hours.
C. Equipment and Facilities Records
Sections 212.20(c), 212.30(b), 212.50(d), and 212.60(f) contain
requirements for records dealing with equipment and physical
facilities. We estimate that it would take approximately 1 hour to
establish and maintain these records for each piece of equipment in
each PET production facility. We estimate that the total burden for
establishing procedures for these records would be approximately 1,935
hours. We estimate that recording maintenance and cleaning information
would take approximately 5 minutes a day for each piece of equipment,
with a total recordkeeping burden of approximately 40,237 hours.
D. Records of Components, Containers, and Closures
Sections 212.20(c) and 212.40(a), (b), and (e) contain requirements
on records regarding receiving and testing of components, containers,
and closures. We estimate that the annual burden for establishing these
records would be approximately 259 hours. We estimate that each
facility would receive approximately 36 shipments annually and would
spend approximately 10 minutes per shipment entering records. The
annual burden for maintaining these records would be approximately 771
hours.
E. Process Verification
Section 212.50(f)(2) requires that any process verification
activities and results be recorded. Because process verification is
only required when results of the production of an entire batch are not
fully verified through finished-product testing, we believe that
process verification will be a very rare occurrence, and we do not
estimate any recordkeeping burden for documenting process verification.
F. Laboratory Testing Records
Sections 212.20(c), 212.60(a), (b), and (g), 212.61(a) through (b),
and 212.70(a), (b), and (d) set out requirements for documenting
laboratory testing and specifications referred to in laboratory
testing, including final release testing and stability testing. Each
PET drug production facility will need to establish procedures and
create forms for the different tests for each product they produce. We
estimate that it will take each facility an average of 1 hour to
establish procedures and create forms for one test. The estimated
annual burden for establishing procedures and creating forms for these
records is approximately 3,225 hours, and the annual burden for
recording laboratory test results is approximately 10,728 hours.
G. Sterility Test Failure Notices
Section 212.70(e) requires PET drug producers to notify all
receiving facilities if a batch fails sterility tests. We believe that
sterility test failures might occur in only 0.05 percent of the batches
of PET drugs produced each year. Therefore, we have estimated in Table
2 that each PET drug producer will need to provide approximately 0.25
sterility test failure notice per year to receiving facilities. The
notice would be provided using email or facsimile transmission and
should take no more than 1 hour.
H. Conditional Final Releases
Section 212.70(f) requires PET drug producers to document any
conditional final releases of a product. We believe that conditional
final releases will be fairly uncommon, but for purposes of the PRA, we
estimated that each PET production facility would have one conditional
final release a year and would spend approximately 1 hour documenting
the release and notifying receiving facilities. The estimate of one
conditional final release per year per facility is an appropriate
average number because many facilities may have no conditional final
releases while others might have only a few.
I. Out-of-Specification Investigations
Sections 212.20(c) and 212.71(a) and (b) require PET drug producers
to establish procedures for investigating products that do not conform
to specifications and conduct these investigations as needed. We
estimate that it will take approximately 1 hour annually to record and
update these procedures for each PET production facility. We also
estimate, for purposes of the PRA, that 36 out-of-specification
investigations would be conducted at each facility each year and that
it would take approximately 1 hour to document the investigation, which
results in an annual burden of 4,644 hours.
J. Reprocessing Procedures
Sections 212.20(c) and 212.71(d) require PET drug producers to
establish and document procedures for reprocessing PET drugs. We
estimate that it will take approximately 1 hour a year to document
these procedures for each PET production facility. We do not estimate a
separate burden for recording the actual reprocessing, both because we
believe it would be an uncommon event and because the recordkeeping
burden has been included in our estimate for batch production and
control records.
[[Page 17217]]
K. Distribution Records
Sections 212.20(c) and 212.90(a) require that written procedures
regarding distribution of PET drug products be established and
maintained. We estimate that it will take approximately 1 hour annually
to establish and maintain records of these procedures for each PET
production facility. Section 212.90(b) requires that distribution
records be maintained. We estimate that it will take approximately 15
minutes to create an actual distribution record for each batch of PET
drug products, with a total burden of approximately 16,157 hours for
all PET producers.
L. Complaints
Sections 212.20(c) and 212.100 require that PET drug producers
establish written procedures for dealing with complaints, as well as
document how each complaint is handled. We estimate that establishing
and maintaining written procedures for complaints will take
approximately 1 hour annually for each PET production facility and that
each facility will receive approximately one complaint a year and will
spend approximately 30 minutes recording how the complaint was dealt
with.
Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of records per Total annual Average burden Total hours
recordkeepers recordkeeper records per recordkeeper
----------------------------------------------------------------------------------------------------------------
212.20(c) and (e); 212.50(a) 129 1.71 221 20............... 4,420
and (b).
212.20(d) and (e); 212.50(c); 129 501 64,629 .5............... 32,315
212.80(c). (30 min.)........
212.20(c); 212.30(b); 129 15 1,935 1................ 1,935
212.50(d), 212.60(f).
212.30(b); 212.50(d); 129 3,758 484,782 .08.............. 40,237
212.60(f). (5 min.).........
212.20(c); 212.40(a) and (b). 129 2 258 1................ 258
212.40(e).................... 129 36 4,644 .166............. 771
(10 min.)........
212.20(c); 212.60(a) and (b); 129 25 3,225 1................ 3,225
212.61(a); 212.70(a), (b),
and (d).
212.60(g); 212.61(b); 129 501 64,629 .16.............. 10,728
212.70(d)(2) and (d)(3). (10 min.)........
212.70(f).................... 129 1 129 1................ 129
212.20(c); 212.71(a)......... 129 36 4,644 1................ 4,644
212.71(b).................... 129 1 129 1................ 129
212.20(c); 212.71(d)......... 129 1 129 1................ 129
212.20(c); 212.90(a)......... 129 1 129 1................ 129
212.90(b).................... 129 501 64,629 .25.............. 16,157
(15 min.)........
212.20(c); 212.100(a)........ 129 1 129 1................ 129
212.100(b) and (c)........... 129 1 129 .5............... 65
(30 min.)........
----------------------------------------------------------------------------------
Total.................... .............. .............. .............. ................. 115,400
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section Number of frequency of Total annual Hours per Total hours
respondents disclosure disclosures disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
212.70(e).......................................................... 129 .25 32 1 32
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06351 Filed 3-19-13; 8:45 am]
BILLING CODE 4160-01-P
